510(k) K123449
- Device
- BIOMONDE LARVAE
- Applicant
- BIOMONDE (A TRADING NAME OF ZOOBIOTIC LIMITED)
- 510(k) number
- K123449
- Product code
- NQK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-03-05
- Date received
- 2012-11-09
- Regulation
- 510(k) Premarket Notification
- Classification name
- Maggots, Medical
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General & Plastic Surgery
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROSINA ROBINSON RN, MED, RAC
- Address
- 225 Tpke. Rd. Southbrough MA US 01772 01772
FDA Registration Numbers#
- 3005735989
Source Documents#
Other 510(k) Records For Product Code NQK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142020 | LARVAL DEBRIDEMENT THERAPY PRODUCTS - LARVAE 100/200/300 AND BIOBAG 50/100/200/300/400 | Biomonde | 2014-11-05 |
| K131221 | LARVAL DEBRIDEMENT THERAPY PRODUCTS - BIOBAG 50/100/200/300/400 | Biomonde | 2013-08-28 |
| K102827 | MEDICAL MAGGOTS, LESOC | Monarch Labs, LLC | 2011-11-02 |
| K072438 | MEDICAL MAGGOTS, CREATURE COMFORTS | Monarch Labs, LLC | 2007-10-05 |
| K033391 | MEDICAL MAGGOTS | Ronald A. Sherman | 2004-01-12 |
Legacy Summary#
summary
FDA Review#
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