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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Gastrointestinal Motility (Electrical)
510(k) Number K991288
Device Name DISTENDER SERIES II BAROSTAT
Applicant
G & J Electronics, Inc.
6 Dornfell St.
Toronto, Ontario,  CA M2R 2Y6
Applicant Contact SAM JUNDLER
Correspondent
G & J Electronics, Inc.
6 Dornfell St.
Toronto, Ontario,  CA M2R 2Y6
Correspondent Contact SAM JUNDLER
Regulation Number876.1725
Classification Product Code
FFX  
Date Received04/14/1999
Decision Date 06/08/1999
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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