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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 BK870024
Tradename Gambro Welding Device WD2
Device Name Device, Heat Sealing
Original Applicant
Gambro Inc.
23872 kelsey road
barrington,  IL  60010
Regulation Number864.9750
Classification Product Code
KSD  
Date Received09/02/1987
Decision Date 11/02/1987
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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