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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 K842568
Device Name RADIONUCLIDE INFUSION SYSTEM
Applicant
Squibb Diagnostics
P.O. Box 191
New Brunswick,  NJ  08903
Applicant Contact MICHAEL P SWIATOCHA
Correspondent
Squibb Diagnostics
P.O. Box 191
New Brunswick,  NJ  08903
Correspondent Contact MICHAEL P SWIATOCHA
Regulation Number880.5725
Classification Product Code
FRN  
Date Received07/02/1984
Decision Date 10/19/1984
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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