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FDA 510(k) Application Details - K991500
Device Classification Name
Endoscopic Tissue Approximation Device
More FDA Info for this Device
510(K) Number
K991500
Device Name
Endoscopic Tissue Approximation Device
Applicant
SMITH & NEPHEW ENDOSCOPY, INC.
130 FORBES BLVD.
MANSFIELD, MA 02048 US
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Contact
SIGI CARON
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
OCW
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More FDA Info for this Product Code
Date Received
04/29/1999
Decision Date
07/14/1999
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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