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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 BK910005
Tradename Safe-T-Vue Irreversible Temperature Indicator
Device Name Supplies, Blood-Bank
Original Applicant
Whitman Medical Corporation
990 raritan road
clark,  NJ  07066
Regulation Number864.9050
Classification Product Code
KSS  
Date Received12/17/1990
Decision Date 05/12/1992
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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