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FDA 510(k) Application Details - K953647
Device Classification Name
Catheter, Angioplasty, Peripheral, Transluminal
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510(K) Number
K953647
Device Name
Catheter, Angioplasty, Peripheral, Transluminal
Applicant
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
112 BAUER DR.
OAKLAND, NJ 07436 US
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Contact
STEPHEN B ANDERSON
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Regulation Number
870.1250
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Classification Product Code
LIT
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More FDA Info for this Product Code
Date Received
08/04/1995
Decision Date
05/16/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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