FDA 510(k) Application Details - K973844

Device Classification Name System, Gastrointestinal Motility (Electrical)

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510(K) Number K973844
Device Name System, Gastrointestinal Motility (Electrical)
Applicant G & J ELECTRONICS, INC.
6 DORNFELL ST.
TORONTO, ONTARIO M2R 2Y6 CA
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Contact SAM JUNDLER
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Regulation Number 876.1725

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Classification Product Code FFX
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Date Received 10/08/1997
Decision Date 06/04/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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