The following data is part of a premarket notification filed by Covalon Technologies, Inc. with the FDA for Colactive Ag Collagen With Silver Antimicrobial Dressing.
| Device ID | K043296 |
| 510k Number | K043296 |
| Device Name: | COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | COVALON TECHNOLOGIES, INC. 14510 KANDI COURT Largo, FL 33774 |
| Contact | Paul L Guilbaud |
| Correspondent | Paul L Guilbaud COVALON TECHNOLOGIES, INC. 14510 KANDI COURT Largo, FL 33774 |
| 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 | 2004-11-29 |
| Decision Date | 2005-06-06 |
| Summary: | summary |