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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, transfer (blood/plasma)
510(k) Number BK950060
Tradename Y-Type Rejuvenation Set PN7212
Device Name Set, Transfer (Blood/Plasma)
Original Applicant
Cytosol Laboratories, Inc.
55 messina drive
braintree,  MA  02184 6783
Regulation Number864.9875
Classification Product Code
KSB  
Date Received10/27/1995
Decision Date 11/25/1996
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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