The following data is part of a premarket notification filed by Bionova Medical, Inc with the FDA for Sentrex Biosponge Mpd.
| Device ID | K123961 |
| 510k Number | K123961 |
| Device Name: | SENTREX BIOSPONGE MPD |
| Classification | Dressing, Wound, Drug |
| Applicant | BIONOVA MEDICAL, INC 3011 CENTRE OAK WAY SUITE 102 Germantown, TN 38138 |
| Contact | Alex Greene |
| Correspondent | Alex Greene BIONOVA MEDICAL, INC 3011 CENTRE OAK WAY SUITE 102 Germantown, TN 38138 |
| 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 | 2012-12-26 |
| Decision Date | 2013-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850047730107 | K123961 | 000 |
| 00850047730091 | K123961 | 000 |
| 00850047730084 | K123961 | 000 |