FDA 510(k) Application Details - K033269

Device Classification Name Endoscopic Tissue Approximation Device

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510(K) Number K033269
Device Name Endoscopic Tissue Approximation Device
Applicant ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI, OH 45242-2839 US
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Contact GEORGIA C ABERNATHY
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Regulation Number 876.1500

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Classification Product Code OCW
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Date Received 10/09/2003
Decision Date 12/10/2003
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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