FDA 510(k) Application Details - K033135

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

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510(K) Number K033135
Device Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE, CA 95138 US
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Contact MIKE HILLDOERFER
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Regulation Number 876.4300

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Classification Product Code KNS
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Date Received 09/30/2003
Decision Date 08/09/2004
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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