The following data is part of a premarket notification filed by Bionova Medical, Inc with the FDA for Healex Biosponge Wound Dressing.
| Device ID | K112191 |
| 510k Number | K112191 |
| Device Name: | HEALEX BIOSPONGE WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | BIONOVA MEDICAL, INC 901 KING ST SUITE 200 Alexandria, VA 22314 |
| Contact | Deborah Lavoie Grayeski |
| Correspondent | Deborah Lavoie Grayeski BIONOVA MEDICAL, INC 901 KING ST SUITE 200 Alexandria, VA 22314 |
| 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 | 2011-07-29 |
| Decision Date | 2012-06-05 |
| Summary: | summary |