FDA 510(k) Applications for Medical Device:
Suture, Nonabsorbable, Silk
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K990089 | AESCULAP, INC. |
13221 MARICOTTE PLACE | SAN DIEGO | CA | 92130 |
| K000541 | ARC MEDICAL SUPPLIES (BEIJING) CO, LTD. |
40 HILLTOP DR. | SYOSSET | NY | 11791 |
| K071111 | ARROW INTL., INC. |
2400 BERNVILLE RD. | READING | PA | 19605 |
| K024091 | AUROLAB |
6441 ENTERPRISE LN. | MADISON | WI | 53719 |
| K241486 | Covidien |
60 Middletown Ave | North Haven | CT | 06473 |
| K001184 | CP MEDICAL |
836 N.E. 24TH AVE. | PORTLAND | OR | 97232 |
| K982853 | DAVIS & GECK, INC. |
444 MC DONNELL BLVD. | HAZELWOOD | MO | 63042 |
| K023029 | DEMETECH CORP. |
12119 SW 131 AVE. | MIAMI | FL | 33186 |
| K080684 | FOOSIN MEDICAL SUPPLIES INC. |
SUITE 8D, ZHONGXIN ZHONGSHAN | ZHONG SHAN, SHANGHAI | 20030 | |
| K003001 | GRAMSMED LLC |
2225 DAKOTA DR. | GRAFTON | WI | 53024 |
| K221767 | Huaian Seamen Medical Technology Co., LTD |
No. 6, Wangyuan Pioneer Park (Qunli Road) | Huaian | 223008 | |
| K012124 | JOHNSON & JOHNSON MEDICAL (CHINA) LTD. |
#75 NAN GU ZHI ROAD | MONHANG, SHANGHAI | 200245 | |
| K172149 | M/s. Meril Endo Surgery Private Limited |
Third Floor, E1-E3, Meril Park, | Chala, Vapi | 396191 | |
| K160623 | M/S. MERIL ENDO SURGERY PRIVATE LIMITED |
3FL, E1-E3, MERIL PARK, SURVEY NO. 135/2/B & 174/2, | Chala, Vapi | 396191 | |
| K053638 | MANI, INC. |
1301K STREET, N.W. | WASHINGTON | DC | 20005-3373 |
| K960328 | R.K. MEDICAL, L.L.C. |
ONE LETHBRIDGE PLAZA | MAHWAH | NJ | 07430 |
| K222944 | SafePath Medical, Inc. |
21 Water Street - 5th Floor | Amesbury | MA | 01913 |
| K180701 | SafePath Medical, Inc. |
21 Water Street - 5th Floor | Amesbury | MA | 01913 |
| K020901 | SERRAL, S.A. DE C.V. |
5251-18 JOHN TYLER HWY, | WILLIAMSBURG | VA | 23185 |
| K232355 | Shandong Haidike Medical Product Co., Ltd. |
Tianfu Road, Dongcheng District, Shan County | Heze | 274300 | |
| K041514 | SUTURES INDIA PRIVATE LIMITED |
118, 3RD PHASE | BANGALORE | 560-058 | |
| K162396 | TELEFLEX MEDICAL, INC |
3015 CARRINGTON MILL BLVD | MORRISVILLE | NC | 27560 |
| K993999 | TRADING CONSULTANTS AND DISTRIBUTORS INTL., INC. |
157 WINDDANCE DR. | CHICAGO | IL | 60046 |
| K042282 | UNITED MEDICAL INDUSTRIES CO. LTD. |
3RD INDUSTRIAL CITY | RIYADH, CENTRAL PROVINCE | 11553 | |
| K964581 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. | NORWALK | CT | 06856 |
| K980124 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. | NORWALK | CT | 06856 |
| K981128 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. | NORWALK | CT | 06856 |
| K994177 | VISIONARY MEDICAL SUPPLIES, INC. |
4740 CONNECTICUT AVE. N.W. | WASHINGTON | DC | 20008 |
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