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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 BK930025
Tradename Kelsea Clamp Needle Cover & Guide
Device Name Supplies, Blood-Bank
Original Applicant
ICU MEDICAL INC
142 technology drive
irvine,  CA  92718
Regulation Number864.9050
Classification Product Code
KSS  
Date Received08/12/1993
Decision Date 10/28/1993
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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