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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K881201
Device Name HR VACUTRAC
Applicant
Icu Medical, Inc.
23436 Madero St.
Mission Viejo,  CA  92691
Applicant Contact FRED MCLENDON
Correspondent
Icu Medical, Inc.
23436 Madero St.
Mission Viejo,  CA  92691
Correspondent Contact FRED MCLENDON
Regulation Number862.1675
Classification Product Code
JKA  
Date Received03/21/1988
Decision Date 05/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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