The following data is part of a premarket notification filed by Covalon Technologies Ltd. with the FDA for Collagran-collagen Wound Dressing, Collagranag-collagen W/silver Antimicrobial Wound Dressing.
| Device ID | K060804 |
| 510k Number | K060804 |
| Device Name: | COLLAGRAN-COLLAGEN WOUND DRESSING, COLLAGRANAG-COLLAGEN W/SILVER ANTIMICROBIAL WOUND 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-03-24 |
| Decision Date | 2006-04-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00714196503442 | K060804 | 000 |
| 00825439011287 | K060804 | 000 |
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| 30612553024276 | K060804 | 000 |