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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K850507
Device Name CRITIKON I.V. ADMINISTRAION SET
Applicant
Critikon Company, LLC
4110 George Rd.
P.O. Box 22800
Tampa,  FL  33630
Applicant Contact MELANIE SABO
Correspondent
Critikon Company, LLC
4110 George Rd.
P.O. Box 22800
Tampa,  FL  33630
Correspondent Contact MELANIE SABO
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/08/1985
Decision Date 03/07/1985
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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