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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, ureteral, gastro-urology
510(k) Number K933020
Device Name MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER
Applicant
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Applicant Contact LORRAINE HANLEY
Correspondent
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Correspondent Contact LORRAINE HANLEY
Regulation Number876.5130
Classification Product Code
EYB  
Date Received06/22/1993
Decision Date 01/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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