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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name leeches, medicinal
510(k) Number BK251217
Tradename MEDICINAL LEECHES (K132958)
Device Name Leeches, Medicinal
Original Applicant
Biopharm (UK) Ltd.
2 bryngwili road
hendy,  Carmarthenshire,  SA4 OXT, 
Classification Product Code
NRN  
Date Received05/09/2025
Decision Date 02/19/2014
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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