The following data is part of a premarket notification filed by Biomonde (a Trading Name Of Zoobiotic Limited) with the FDA for Biomonde Larvae.
| Device ID | K123449 |
| 510k Number | K123449 |
| Device Name: | BIOMONDE LARVAE |
| Classification | Maggots, Medical |
| Applicant | BIOMONDE (A TRADING NAME OF ZOOBIOTIC LIMITED) 225 Turnpike Road Southborough, MA 01772 |
| Contact | Rosina Robinson Rn, Med, Rac |
| Correspondent | Rosina Robinson Rn, Med, Rac BIOMONDE (A TRADING NAME OF ZOOBIOTIC LIMITED) 225 Turnpike Road Southborough, MA 01772 |
| 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 | 2012-11-09 |
| Decision Date | 2013-03-05 |
| Summary: | summary |