The following data is part of a premarket notification filed by Monarch Labs, Llc. with the FDA for Medical Maggots, Creature Comforts.
Device ID | K072438 |
510k Number | K072438 |
Device Name: | MEDICAL MAGGOTS, CREATURE COMFORTS |
Classification | Maggots, Medical |
Applicant | MONARCH LABS, LLC. 17875 SKY PARK CIRCLE, SUITE K Irvine, CA 92614 |
Contact | Ronald S Sherman |
Correspondent | Ronald S 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-30 |
Decision Date | 2007-10-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B698LFDJ880 | K072438 | 000 |
B698CC24241 | K072438 | 000 |
B698CC441 | K072438 | 000 |
B698CC881 | K072438 | 000 |
B698CCKH1 | K072438 | 000 |
B698CCPH1 | K072438 | 000 |
B698MM2501 | K072438 | 000 |
B698LF330 | K072438 | 000 |
B698LF660 | K072438 | 000 |
B698LFDJ440 | K072438 | 000 |
B698CC12121 | K072438 | 000 |