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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, heat-sealing
510(k) Number BK910024
Tradename SEBRA/MODEL #2100 TUBE SEALER
Device Name Device, Heat Sealing
Original Applicant
Engineering & Research Associates, Inc.
500 north tucson boulevard (era plaza)
tucson,  AZ  85716
Regulation Number864.9750
Classification Product Code
KSD  
Date Received08/23/1991
Decision Date 11/05/1992
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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