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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wire, guide, catheter
510(k) Number K897152
Device Name CRAGG CONVERTIBLE WIRE
Applicant
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
P.O. BOX 7407
WATERTOWN,  MA  02272
Applicant Contact LEO BASTA
Correspondent
BOSTON SCIENTIFIC CORP.
480 PLEASANT ST.
P.O. BOX 7407
WATERTOWN,  MA  02272
Correspondent Contact LEO BASTA
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/26/1989
Decision Date 02/22/1990
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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