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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 K883609
Device Name ACCES. PACKAGE FOR USE W/CARDIOGEN-82 GENERATOR
Applicant
Squibb Diagnostics
P.O. Box 191
New Brunswick,  NJ  08903
Applicant Contact LEONARD M BAUM
Correspondent
Squibb Diagnostics
P.O. Box 191
New Brunswick,  NJ  08903
Correspondent Contact LEONARD M BAUM
Regulation Number880.5725
Classification Product Code
FRN  
Date Received08/22/1988
Decision Date 04/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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