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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name maggots, medical
510(k) Number BK251213
Tradename Medical Maggots and maggot confinement dressings (K102827)
Device Name Maggots, Medical
Original Applicant
MONARCH LABS, LLC.
17875 sky park circle
suite k
irvine,  CA  92614
Classification Product Code
NQK  
Date Received05/09/2025
Decision Date 11/02/2011
Decision substantially equivalent (SE)
Review Advisory Committee General & Plastic Surgery
Type 510(k) Special
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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