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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K903606
Device Name GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCER
Applicant
North American Instrument Corp.
Glens Falls,  NY  12801
Applicant Contact ROBERT E FRANKLIN
Correspondent
North American Instrument Corp.
Glens Falls,  NY  12801
Correspondent Contact ROBERT E FRANKLIN
Regulation Number870.1250
Classification Product Code
LIT  
Date Received07/30/1990
Decision Date 09/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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