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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K983415
Device Name DELIVERY SHEATH
Applicant
Conway Stuart Medical, Inc.
735 Palomar St.
Sunnyvale,  CA  94086
Applicant Contact THOMAS WEHMAN
Correspondent
Conway Stuart Medical, Inc.
735 Palomar St.
Sunnyvale,  CA  94086
Correspondent Contact THOMAS WEHMAN
Regulation Number876.1500
Classification Product Code
FED  
Date Received09/29/1998
Decision Date 12/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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