FDA 510(k) Applications for Medical Device:
Suture, Surgical, Absorbable, Polydioxanone
FDA 510(k) Number |
Applicant |
Address |
City / Country |
State / Province |
Postal Code |
K031216 |
AESCULAP |
3773 CORPORATE PKWY.
| CENTER VALLEY |
PA |
18034 |
K113744 |
ANGIOTECH |
100 DENNIS DRIVE
| READING |
PA |
19606 |
K120827 |
ANGIOTECH |
100 DENNIS DRIVE
| READING |
PA |
19606 |
K022666 |
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
1591 S. MOORLAND RD.
| NEW BERLIN |
WI |
53151 |
K150553 |
ASSUT EUROPE |
ZONA INDUSTRIALE
| MAGLIANO DEI MARSI |
|
1-67062 |
K120284 |
COLOPLAST A/S |
1601 WEST RIVER ROAD NORTH
| MINNEAPOLIS |
MN |
55411 |
K013274 |
CP MEDICAL |
836 N.E. 24TH AVE.
| PORTLAND |
OR |
97232 |
K030786 |
CP MEDICAL |
836 N.E. 24TH AVE.
| PORTLAND |
OR |
97232 |
K082097 |
DEMETECH CORP. |
8935 NW 27TH STREET
| MIAMI |
FL |
33172 |
K191361 |
DemeTECH Corporation |
14175 NW 60th Ave
| Miami Lakes |
FL |
33014 |
K181582 |
Demetech Corporation |
14175 NW 60th Ave
| Miami Lakes |
FL |
33014 |
K043298 |
Depuy Mitek |
249 VANDERBILT DR.
| NORWOOD |
MA |
02062 |
K080918 |
Depuy Mitek |
325 Paramount Drive
| Raynham |
MA |
02767 |
K040004 |
Depuy Mitek |
249 VANDERBILT DR.
| NORWOOD |
MA |
02062 |
K123668 |
DEPUY MITEK INC., A JOHNSON AND JOHNSON COMPANY |
325 Paramount Drive
| Raynham |
MA |
02767 |
K160761 |
DONGWON MEDICAL CO., LTD. |
201-HO, 35, SAAM-RO 340BEON-GIL
| Gwangju |
|
62328 |
K212380 |
Ethicon, Inc. |
1000 Route 202
| Raritan |
NJ |
08869 |
K061037 |
ETHICON, INC. |
ROUTE 22 WEST
| SOMERVILLE |
NJ |
08876 |
K113004 |
ETHICON, INC. |
ROUTE 22 WEST
| SOMERVILLE |
NJ |
08876-0151 |
K192144 |
Ethicon, Inc. |
Route 22 West, P.O. Box 151
| Somerville |
NJ |
08876-0151 |
K150670 |
ETHICON, INC. |
ROUTE 22 WEST, PO BOX 151
| SOMERVILLE |
NJ |
08876 |
K141776 |
ETHICON, INC. |
ROUTE 22 WEST
| SOMERVILLE |
NJ |
08876-0151 |
K182873 |
Ethicon, Inc. |
Route 22 West, P.O. Box 151
| Somerville |
NJ |
08876 |
K172602 |
Feeltech Co., Ltd. |
3,4 Floor Standard Factory 2-dong, 15 Jayumuyeok 2-gil
| Gunsan-si |
|
573-540 |
K073614 |
FOOSIN MEDICAL SUPPLIES INC. |
SUITE 8D, ZHONGXIN ZHONGSHAN
| ZHONG SHAN, SHANGHAI |
|
20030 |
K201139 |
Foosin Medical Supplies Inc., Ltd. |
No.20, Xingshan Road, Weihai Torch Hi-tech Science Park
| Weihai |
|
264210 |
K030212 |
GENZYME BIOSURGERY |
600 AIRPORT RD.
| FALL RIVER |
MA |
02720-4740 |
K192423 |
Hans Biomed Corporation |
7, Jeongui-ro 8-gil, Songpa-gu
| Seoul |
|
05836 |
K220549 |
Hans Biomed Corporation |
64, Yuseong-Daero 1628 Beon-Gil
| Yuseong-Gu |
|
34054 |
K130191 |
HANSBIOMED CORPORATION |
325 N PUENTE ST
| BREA |
CA |
92821 |
K041048 |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
55 Northern Blvd.
| Great Neck |
NY |
11021 |
K031443 |
LSI SOLUTIONS |
7796 VICTOR-MENDON RD.
| VICTOR |
NY |
14564 |
K190264 |
MEDITIME Co., Ltd |
#605 Medical Device Complex, 200, Gieupdosi-ro,
| Won Ju |
|
90010 |
K161737 |
MYCO MEDICAL |
158 TOWERVIEW COURT
| CARY |
NC |
27513 |
K162366 |
OV WORLD CO., LTD |
(GASAN-DONG, FORMATEC BD)A-202,213 205-28, GASAN DIGITAL 1-R
| SEOUL |
|
|
K210871 |
PDO MAX, Inc. |
4971 Bear Road
| Liverpool |
NY |
13088 |
K190245 |
PDO MAX, Inc. |
4971 Bear Road
| Liverpool |
NY |
13088 |
K042075 |
QUILL MEDICAL, INC. |
1600 STEWART AVE.
| WESTBURY |
NY |
11590 |
K051609 |
QUILL MEDICAL, INC. |
2505 MERIDIAN PKWY.
| RESEARCH TRIANGLE PARK |
NC |
27713 |
K100461 |
RIVERPOINT MEDICAL |
825 NE 25TH AVE.
| PORTLAND |
OR |
97232 |
K053380 |
SURGICAL SPECIALTIES CORP. |
100 DENNIS DR.
| READING |
PA |
19606 |
K080680 |
SURGICAL SPECIALTIES CORP. |
13921 PARK CENTER RD.
| HERNDON |
VA |
20171 |
K080985 |
SURGICAL SPECIALTIES CORP. |
13921 PARK CENTER RD.
| HERNDON |
VA |
20171 |
K071989 |
SURGICAL SPECIALTIES CORP. |
100 DENNIS DR.
| READING |
PA |
19606 |
K063680 |
SURGICAL SPECIALTIES CORP. |
100 DENNIS DR.
| READING |
PA |
19606 |
K123877 |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
100 DENNIS DR.
| READING |
PA |
19606 |
K133420 |
SURGICAL SPECIALTIES CORP. DBA ANGIOTECH |
100 DENNIS DR.
| READING |
PA |
19606 |
K132268 |
SURGICAL SPECIALTIES CORPORATION DBA ANGIOTECH |
100 DENNIS DRIVE
| READING |
PA |
19606 |
K081001 |
SUTURES INDIA PVT., LTD. |
472 D, 13TH CROSS, 4TH PHASE
| BANGALORE |
|
560058 |
K100780 |
UNILENE S.A.C. |
5401 S. COTTONWOOD CT.
| GREENWOOD VILLAGE |
CO |
80121 |
K042285 |
UNITED MEDICAL INDUSTRIES CO. LTD. |
3RD INDUSTRIAL CITY
| RIYADH, CENTRAL PROVINCE |
|
11553 |
K160705 |
Y. JACOBS MEDICAL, INC |
6F SANGKYUNG BLDG. 669 SEOLLEUNG-RO
| SEOUL |
|
135-830 |
K143413 |
Y. Jacobs Medical, Inc. |
6F Sangkyeong Bldg. 669 Seolleung-ro, Gangnam-gu
| Seoul |
|
135830 |
|
|