The following data is part of a premarket notification filed by Hartmann-conco Inc. with the FDA for Collasorb Collagen Wound Dressing.
| Device ID | K091338 |
| 510k Number | K091338 |
| Device Name: | COLLASORB COLLAGEN WOUND DRESSING |
| Classification | Dressing, Wound, Collagen |
| Applicant | HARTMANN-CONCO INC. 1468 HARWELL AVE. Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith HARTMANN-CONCO INC. 1468 HARWELL AVE. Crofton, MD 21114 |
| 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 | 2009-05-06 |
| Decision Date | 2009-08-26 |
| Summary: | summary |