FDA 510(k) Applications for Medical Device:
Perineometer
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K142355 | Advanced Tactile Imaging, Inc. |
1459 Lower Ferry Raod | Trenton | NJ | 08618 |
| K143580 | ANALYTICA LTD |
320 ADELAIDE STREET | BRISBANE | 4000 | |
| K160758 | ANALYTICA LTD. |
320 ADELAIDE STREET | BRISBANE | 4000 | |
| K082436 | APIMEDS, INC |
5401 S. COTTONWOOD CT | GREENWOOD VILLAGE | CO | 80121 |
| K162689 | BIOINFINITY (M) SDN. BHD. |
NO. 21, JALAN 4/62 A, BANDAR MENJALARA, KEPONG | KEPONG | 52200 | |
| K141893 | BIOINFINITY (M)SDN.BHD. |
816 CONGRESS AVENUE, SUITE1400 | AUSTIN | TX | 78701 |
| K970145 | BIOSEARCH MEDICAL PRODUCTS, INC. |
35 INDUSTRIAL PKWY. | SOMERVILLE | NJ | 08876 |
| K945611 | CARDIO DESIGN PTY. LTD. |
7089 CROWNE OAK RD. | EDEN PRAIRIE | MN | 55344 |
| K983052 | CARDIO DESIGN PTY. LTD. |
P.O. BOX 6407 BHBC | BAULKHAM HILLS NSW | 2153 | |
| K002830 | COLONIAL MEDICAL SUPPLY |
1350 E. FLAMINGO RD. # 343 | LAS VEGAS | NV | 89119 |
| K994079 | DESCHUTES MEDICAL PRODUCTS, INC. |
1011 S.W. EMKAY DR., SUITE 104 | BEND | OR | 97702 |
| K013612 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K013653 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K960311 | HOLLISTER, INC. |
2000 HOLLISTER DR. | LIBERTYVILLE | IL | 60048 |
| K122800 | KAMABRY, INC., DBA INNER PEACE FOR WOMEN |
1468 HARWELL HAVE | CROFTON | MD | 21114 |
| K023305 | KEGELMASTER 2000 LTD. |
P.O. BOX 4341 | CROFTON | MD | 21114 |
| K993411 | MEGA ELECTRONICS LTD. |
200 NORTH MAIN ST. | EAST LONGMEADOW | MA | 01028 |
| K021115 | NAISSANCE HOLDINGS, LC |
800 CONNECTICUT AVENUE, N.W. | WASHINGTON | DC | 20006 |
| K002617 | NEEN DESIGN LTD. |
OLD PHARMACY YARD, CHURCH ST. | DEREHAM, NORFOLK | NR19 1DJ | |
| K121902 | ORELLE CORPORATION LTD |
4739 - 44TH AVE S.W., UNIT 403 | SEATTLE | WA | 98116 |
| K011688 | PELVICFLEX, INC. |
55 Northern Blvd. | Great Neck | NY | 11021 |
| K210764 | Pelvital USA, Inc. |
1000 LaSalle Avenue, SCH 435 | Minneapolis | MN | 55403 |
| K212655 | Pelvital USA, Inc. |
1000 LaSalle Avenue, SCH 435 | Minneapolis | MN | 55403 |
| K200409 | Pelvital USA, Inc. |
1000 LaSalle Avenue, SCH 435 | Minneapolis | MN | 55403 |
| K193364 | Plus EV Holdings dba Intimate Rose |
1700 Iron St. | North Kansas City | MO | 64116 |
| K002043 | PURDUE TECHNOLOGY PARK |
3000 KENT AVE. | WEST LAFAYETTE | IN | 47906 |
| K171896 | Ralston Group |
656 Lake Lanier Rd. | Selma | AL | 36701 |
| K140780 | REGULATORY INSIGHT, INC. |
33 Golden Eagle Lane | Littleton | CO | 80127 |
| K133990 | REMENDIUM LABS, LLC |
340 EAST PARKER ROAD | BATON ROUGE | LA | 70803 |
| K192270 | Renovia Inc. |
263 Summer St., 5th Floor | Boston | MA | 02210 |
| K180637 | Renovia Inc. |
263 Summer St., 5th Floor | Boston | MA | 02210 |
| K213913 | Renovia Inc. |
263 Summer St, 5th Floor | Boston | MA | 02210 |
| K212495 | Renovia Inc. |
263 Summer St. 5th Floor | Boston | MA | 02210 |
| K002834 | SRS MEDICAL SYSTEMS, INC. |
14950 N.E. 95TH ST. | REDMOND | WA | 98052 |
| K960508 | THE PROMETHEUS GROUP |
80 BOW ST. | PORTSMOUTH | NH | 03801 |
| K974036 | THE PROMETHEUS GROUP |
2 MALLARDS COVE | DUXBURY | MA | 02332 |
| K981277 | VERIMED HOLDINGS, INC. |
11950 N.W. 39TH ST., SUITE D | CORAL SPRINGS | FL | 33065 |
| K221476 | X6 Innovations |
128 Rue De La BoΘtie | Paris | 75008 |
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