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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name maggots, medical
510(k) Number BK251216
Tradename Larval Debridemnt Therapy Products - BioBag 50/I100/200/300/400 (K131221)
Device Name Maggots, Medical
Original Applicant
BioMonde
62 forest street
suite 300
marlborough,  MA  01752
Classification Product Code
NQK  
Date Received05/09/2025
Decision Date 08/28/2013
Decision substantially equivalent (SE)
Review Advisory Committee General & Plastic Surgery
Type 510(k) Traditional
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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