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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 K992320
Device Name MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
5905 NATHAN LN.
PLYMOUTH,  MN  55442
Applicant Contact RONALD W BENNETT
Correspondent
BOSTON SCIENTIFIC CORP.
5905 NATHAN LN.
PLYMOUTH,  MN  55442
Correspondent Contact RONALD W BENNETT
Regulation Number870.1250
Classification Product Code
LIT  
Date Received07/12/1999
Decision Date 05/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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