The following data is part of a premarket notification filed by Basf Venture Capital America Inc. with the FDA for Enluxtra Humifiber Wound Dressing.
| Device ID | K122297 |
| 510k Number | K122297 |
| Device Name: | ENLUXTRA HUMIFIBER WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | BASF VENTURE CAPITAL AMERICA INC. 100 CAMPUS DRIVE Floram Park, NJ 07932 |
| Contact | Nadi Ergenc, Ph.d. |
| Correspondent | Nadi Ergenc, Ph.d. BASF VENTURE CAPITAL AMERICA INC. 100 CAMPUS DRIVE Floram Park, NJ 07932 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-31 |
| Decision Date | 2012-08-28 |
| Summary: | summary |