The following data is part of a premarket notification filed by Innocoll Pharmaceuticals with the FDA for Collaguard, Model Fcia,fcib,fcic,and Fcid.
| Device ID | K061746 |
| 510k Number | K061746 |
| Device Name: | COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID |
| Classification | Dressing, Wound, Collagen |
| Applicant | INNOCOLL PHARMACEUTICALS IDA BUSINESS AND TECHNOLOGY PARK, GARRYCASTLE Athlone, Co. Westmeath, IE |
| Contact | Aaron Wyse |
| Correspondent | Aaron Wyse INNOCOLL PHARMACEUTICALS IDA BUSINESS AND TECHNOLOGY PARK, GARRYCASTLE Athlone, Co. Westmeath, IE |
| 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 | 2006-06-21 |
| Decision Date | 2006-10-02 |
| Summary: | summary |