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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 K851848
Device Name PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER
Applicant
Mansfield Scientific, Inc.
135 Forbes Blvd.
Mansfield,  MA  02048
Applicant Contact BRUCE BEAUCHEMIN
Correspondent
Mansfield Scientific, Inc.
135 Forbes Blvd.
Mansfield,  MA  02048
Correspondent Contact BRUCE BEAUCHEMIN
Regulation Number870.1250
Classification Product Code
LIT  
Date Received04/26/1985
Decision Date 07/19/1985
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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