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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 leeches, medicinal
510(k) Number BK251218
Tradename Medicinal Leech (K140907)
Device Name Leeches, Medicinal
Original Applicant
CAROLINA BIOLOGICAL SUPPLY COMPANY
2700 york rd
burlington,  NC  27215
Classification Product Code
NRN  
Date Received05/09/2025
Decision Date 08/07/2015
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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