FDA 510(k) Application Details - K031169

Device Classification Name System, Gastrointestinal Motility (Electrical)

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510(K) Number K031169
Device Name System, Gastrointestinal Motility (Electrical)
Applicant SIERRA SCIENTIFIC INSTRUMENTS, INC.
16787 BERNARDO CENTER DR.
SUITE A-1
SAN DIEGO, CA 92128 US
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Contact SEAN M CURRY
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Regulation Number 876.1725

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Classification Product Code FFX
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Date Received 04/14/2003
Decision Date 12/12/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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