The following data is part of a premarket notification filed by Convatec Limited with the FDA for Aquacel Ag Surgical Sp Dressing.
| Device ID | K152926 |
| 510k Number | K152926 |
| Device Name: | AQUACEL Ag Surgical SP Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | CONVATEC LIMITED FIRST AVENUE, DEESIDE INDUSTRIAL PARK Deeside, GB Ch5 2nu |
| Contact | Aaron Sibley |
| Correspondent | Aaron Sibley CONVATEC LIMITED FIRST AVENUE, DEESIDE INDUSTRIAL PARK Deeside, GB Ch5 2nu |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-10-05 |
| Decision Date | 2016-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10768455200266 | K152926 | 000 |
| 00768455130795 | K152926 | 000 |
| 00768455130788 | K152926 | 000 |
| 00768455130771 | K152926 | 000 |
| 00768455130764 | K152926 | 000 |
| 00768455130603 | K152926 | 000 |