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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 set, transfer (blood/plasma)
510(k) Number BK860006
Tradename Cutter PPP Harness
Device Name Set, Transfer (Blood/Plasma)
Original Applicant
Haemonetics Manufacturing Inc.
400 wood road
braintree,  MA  02184
Regulation Number864.9875
Classification Product Code
KSB  
Date Received01/27/1986
Decision Date 09/17/1986
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
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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