The following data is part of a premarket notification filed by Covalon Technologies Ltd. with the FDA for Covaclearag Collagen With Silver Antimicrobial Gel Sheet Dressing.
| Device ID | K052696 |
| 510k Number | K052696 |
| Device Name: | COVACLEARAG COLLAGEN WITH SILVER ANTIMICROBIAL GEL SHEET DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | COVALON TECHNOLOGIES LTD. 2033 IVERSON LANES Waxhaw, NC 28173 |
| Contact | Jacques Lemmetti |
| Correspondent | Jacques Lemmetti COVALON TECHNOLOGIES LTD. 2033 IVERSON LANES Waxhaw, NC 28173 |
| 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 | 2005-09-28 |
| Decision Date | 2006-02-03 |
| Summary: | summary |