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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 K874372
Device Name HR(TM) NEEDLE AND SYRINGE
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 Received10/26/1987
Decision Date 11/06/1987
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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