The following data is part of a premarket notification filed by Monarch Labs, Llc. with the FDA for Medical Maggots, Lesoc.
| Device ID | K102827 |
| 510k Number | K102827 |
| Device Name: | MEDICAL MAGGOTS, LESOC |
| Classification | Maggots, Medical |
| Applicant | MONARCH LABS, LLC. 17875 SKY PARK CIRCLE, SUITE K Irvine, CA 92614 |
| Contact | Ronald Sherman |
| Correspondent | Ronald Sherman MONARCH LABS, LLC. 17875 SKY PARK CIRCLE, SUITE K Irvine, CA 92614 |
| Product Code | NQK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-29 |
| Decision Date | 2011-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B698LS8X120 | K102827 | 000 |
| B698LS6X80 | K102827 | 000 |
| B698LS4X60 | K102827 | 000 |
| B698LS2X30 | K102827 | 000 |
| B698LS24X360 | K102827 | 000 |
| B698LS18X240 | K102827 | 000 |
| B698LS12X180 | K102827 | 000 |