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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 K852140
Device Name NAMIC CONTRAST & FLUID DELIVERY SPIKES(VARIOUS)
Applicant
North American Instrument Corp.
Hudson Falls,  NY  12839
Applicant Contact PHILLIP H MORSE
Correspondent
North American Instrument Corp.
Hudson Falls,  NY  12839
Correspondent Contact PHILLIP H MORSE
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/16/1985
Decision Date 05/30/1985
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
Recalls CDRH Recalls
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