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FDA 510(k) Application Details - K964100
Device Classification Name
Sigmoidoscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K964100
Device Name
Sigmoidoscope And Accessories, Flexible/Rigid
Applicant
VISION-SCIENCES, INC.
6 STRATHMORE RD.
NATICK, MA 01760 US
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Contact
PAMELA PAPINEAU
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
FAM
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More FDA Info for this Product Code
Date Received
10/11/1996
Decision Date
12/16/1996
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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