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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K872580
Device Name HR (TM) COLLECTION SYSTEM
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 Number880.5570
Classification Product Code
FMI  
Date Received06/30/1987
Decision Date 08/13/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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