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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K960801
Device Name SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)
Applicant
North American Instrument Corp.
Pruyns Island Rd.
Glens Falls,  NY  12801
Applicant Contact MARY MEAGHER RUBIN
Correspondent
North American Instrument Corp.
Pruyns Island Rd.
Glens Falls,  NY  12801
Correspondent Contact MARY MEAGHER RUBIN
Regulation Number870.1200
Classification Product Code
DQO  
Date Received02/27/1996
Decision Date 03/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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