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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cholangiography
510(k) Number K932228
Device Name MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Applicant Contact SHERI D O'BRIEN
Correspondent
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Correspondent Contact SHERI D O'BRIEN
Regulation Number878.4200
Classification Product Code
GBZ  
Subsequent Product Code
GCJ  
Date Received05/07/1993
Decision Date 08/10/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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