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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K875174
Device Name RATEMINDER V INFUSION PUMP
Applicant
CRITIKON COMPANY,LLC
4110 GEORGE RD.
P.O. BOX 22800
TAMPA,  FL  33630
Applicant Contact RAYMOND E URSICK
Correspondent
CRITIKON COMPANY,LLC
4110 GEORGE RD.
P.O. BOX 22800
TAMPA,  FL  33630
Correspondent Contact RAYMOND E URSICK
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/17/1987
Decision Date 03/29/1988
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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