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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscopy Kit
510(k) Number K942677
Device Name GEENEN/ZEBRA GUIDELINES
Applicant
BOSTON SCIENTIFIC CORP.
400, 480, 610, 650 PLEASANT ST
WATERTOWN,  MA  02172
Applicant Contact JOSEPH J CURTIS
Correspondent
BOSTON SCIENTIFIC CORP.
400, 480, 610, 650 PLEASANT ST
WATERTOWN,  MA  02172
Correspondent Contact JOSEPH J CURTIS
Regulation Number876.1500
Classification Product Code
FDE  
Subsequent Product Code
GCA  
Date Received06/07/1994
Decision Date 07/21/1994
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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