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FDA 510(k) Application Details - K980815
Device Classification Name
Endoscopic Tissue Approximation Device
More FDA Info for this Device
510(K) Number
K980815
Device Name
Endoscopic Tissue Approximation Device
Applicant
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI, OH 45242-2839 US
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Contact
LORRI CHAVEZ
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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
03/03/1998
Decision Date
05/01/1998
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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