FDA 510(k) Application Details - K031026

Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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510(K) Number K031026
Device Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant ENDO-THERAPEUTICS, INC.
1183 CEDAR ST.
SAFETY HARBOR, FL 34695-2908 US
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Contact TODD ADKISSON
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Regulation Number 876.4300

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Classification Product Code KNS
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Date Received 03/31/2003
Decision Date 06/27/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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