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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name supplies, blood-bank
510(k) Number BK860019
Tradename SEBRA Model 1300 (Tube Stripper)
Device Name Supplies, Blood-Bank
Original Applicant
Engineering & Research Associates, Inc.
500 north tucson boulevard (era plaza)
tucson,  AZ  85716
Regulation Number864.9050
Classification Product Code
KSS  
Date Received04/24/1986
Decision Date 09/29/1986
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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