The following data is part of a premarket notification filed by Biomonde with the FDA for Larval Debridement Therapy Products - Biobag 50/100/200/300/400.
| Device ID | K131221 |
| 510k Number | K131221 |
| Device Name: | LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400 |
| Classification | Maggots, Medical |
| Applicant | BIOMONDE 62 FOREST STREET, STE 300 Marlborough, MA 01752 |
| Contact | Rosina Robinsion, Rn, Med, Rac |
| Correspondent | Rosina Robinsion, Rn, Med, Rac BIOMONDE 62 FOREST STREET, STE 300 Marlborough, MA 01752 |
| Product Code | NQK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-30 |
| Decision Date | 2013-08-28 |
| Summary: | summary |