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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 K962829
Device Name HARMAC BALLOON ANGIOGRAPHIC CATHETER
Applicant
Harmac Medical Products, Inc.
2201 Bailey Ave.
Buffalo,  NY  14211
Applicant Contact JOSEPH M KNOIECZNY
Correspondent
Harmac Medical Products, Inc.
2201 Bailey Ave.
Buffalo,  NY  14211
Correspondent Contact JOSEPH M KNOIECZNY
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/28/1996
Decision Date 10/16/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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