The following data is part of a premarket notification filed by Collafirm Llc with the FDA for Fibrillar Collagen Wound Dressing.
| Device ID | K120250 |
| 510k Number | K120250 |
| Device Name: | FIBRILLAR COLLAGEN WOUND DRESSING |
| Classification | Dressing, Wound, Collagen |
| Applicant | COLLAFIRM LLC 7 DEER PARK DRIVE SUITE M-7 Monmouth Junction, NJ 08852 |
| Contact | Surendra Batra |
| Correspondent | Surendra Batra COLLAFIRM LLC 7 DEER PARK DRIVE SUITE M-7 Monmouth Junction, NJ 08852 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-27 |
| Decision Date | 2013-04-21 |
| Summary: | summary |