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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 K973563
Device Name BIPORE BALLOON DILATATION CATHETER
Applicant
Bipore, Inc.
31 Industrial Pkwy.
Northvale,  NJ  07647
Applicant Contact DURMUS KOCH
Correspondent
Bipore, Inc.
31 Industrial Pkwy.
Northvale,  NJ  07647
Correspondent Contact DURMUS KOCH
Regulation Number870.1250
Classification Product Code
LIT  
Date Received09/19/1997
Decision Date 04/01/1998
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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