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FDA 510(k) Applications for Medical Device:
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| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K971597 | COLOPLAST CORP. |
6401 MEADOWS WEST DR. | FORT WORTH | TX | 76132 |
| K991061 | DERMAPHYLYX, INC. |
78-E,, OLYMPIA AVE. | WOBURN | MA | 01801-3933 |
| K992094 | GILTECH PLUS, INC. |
P.O. BOX 728 | MILFORD | PA | 18337 |
| K082865 | GORBEC PHARMACEUTICAL SERVICES, INC. |
2445 SOUTH ALSTON AVENUE | DURHAM | NC | 27713 |
| K073246 | GORBEC PHARMACEUTICAL SERVICES, INC. |
2445 SOUTH ALSTON AVENUE | DURHAM | NC | 27713 |
| K972646 | LUDLOW TECHNICAL PRODUCTS |
TWO LUDLOW PARK | CHICOPEE | MA | 01022 |
| K962352 | NORTH AMERICAN STERILIZATION & PACKAGING CO. |
18 WHITE LAKE RD. | SPARTA | NJ | 07871 |
| K083721 | RIVER'S EDGE PHARMACEUTICALS, LLC |
2445 SOUTH ALSTON AVE. | DURHAM | NC | 27713 |