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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 K973013
Device Name OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER
Applicant
Vas-Cath, Inc.
8195 Industrial Blvd.
Covington,  GA  30014
Applicant Contact DONNA J WILSON
Correspondent
Vas-Cath, Inc.
8195 Industrial Blvd.
Covington,  GA  30014
Correspondent Contact DONNA J WILSON
Regulation Number870.1250
Classification Product Code
LIT  
Date Received08/13/1997
Decision Date 06/19/1998
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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