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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 BK940019
Tradename Hemopharm PB-500 Pocket Sealer
Device Name Supplies, Blood-Bank
Original Applicant
Insta Cool, Inc of North America
11300 sanders drive, suite 14
rancho cordova,  CA  95742
Regulation Number864.9050
Classification Product Code
KSS  
Date Received04/28/1994
Decision Date 09/26/1994
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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