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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 BK251252
Tradename MEDIFLY Maggots
Device Name Maggots, Medical
Original Applicant
CUPRINA PTE. LTD.
1090 lower delta road
#06-08
Singapore,  169201,  SINGAPORE
Classification Product Code
NQK  
Date Received07/18/2025
Decision Date 06/12/2026
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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