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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 K873729
Device Name RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET
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 Number880.5440
Classification Product Code
FPA  
Date Received09/15/1987
Decision Date 12/29/1987
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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