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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 K943298
Device Name MS CLASSIQUE BALLOON CATHETER
Applicant
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
112 BAUER DR.
OAKLAND,  NJ  07436
Applicant Contact STEPHEN B ANDERSON
Correspondent
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
112 BAUER DR.
OAKLAND,  NJ  07436
Correspondent Contact STEPHEN B ANDERSON
Regulation Number870.1250
Classification Product Code
LIT  
Date Received07/08/1994
Decision Date 09/08/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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