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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 K902317
Device Name PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH.
Applicant
Mallinckrodt Medical
675 Mcdonnell Blvd. P.O. Box
5840
St Louis,  MO  63134
Applicant Contact DAVID E BROWN
Correspondent
Mallinckrodt Medical
675 Mcdonnell Blvd. P.O. Box
5840
St Louis,  MO  63134
Correspondent Contact DAVID E BROWN
Regulation Number870.1250
Classification Product Code
LIT  
Date Received05/23/1990
Decision Date 12/03/1990
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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