The following data is part of a premarket notification filed by Advanced Medical Solutions Ltd. with the FDA for Silver Foam Wound Dressing.
Device ID | K032742 |
510k Number | K032742 |
Device Name: | SILVER FOAM WOUND DRESSING |
Classification | Dressing, Wound, Drug |
Applicant | ADVANCED MEDICAL SOLUTIONS LTD. ROAD THREE WINSFORD INDUSTRIAL ESTATE Winsford, Cheshire, GB Cw7 3pd |
Contact | John Green |
Correspondent | John Green ADVANCED MEDICAL SOLUTIONS LTD. ROAD THREE WINSFORD INDUSTRIAL ESTATE Winsford, Cheshire, GB Cw7 3pd |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2003-09-04 |
Decision Date | 2004-08-16 |
Summary: | summary |