The following data is part of a premarket notification filed by Convatec, A Division Of E.r. Squibb & Sons, L.l.c. with the FDA for Silver Impregnated Hydrofiber Dressing Reinforced With Nylon (flat).
| Device ID | K090254 |
| 510k Number | K090254 |
| Device Name: | SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT) |
| Classification | Dressing, Wound, Drug |
| Applicant | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| Contact | Patricia Kearins |
| Correspondent | Patricia Kearins CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. 200 HEADQUARTERS PARK DR. Skillman, NJ 08558 |
| 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 | 2009-02-02 |
| Decision Date | 2009-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00768455124268 | K090254 | 000 |
| 00768455124138 | K090254 | 000 |
| 00768455124145 | K090254 | 000 |
| 00768455124152 | K090254 | 000 |
| 00768455124169 | K090254 | 000 |
| 00768455124176 | K090254 | 000 |
| 00768455124237 | K090254 | 000 |
| 00768455124244 | K090254 | 000 |
| 00768455124251 | K090254 | 000 |
| 00768455124121 | K090254 | 000 |