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FDA 510(k) Application Details - K033135
Device Classification Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
More FDA Info for this Device
510(K) Number
K033135
Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant
Stryker Endoscopy
5900 OPTICAL CT.
SAN JOSE, CA 95138 US
Other 510(k) Applications for this Company
Contact
MIKE HILLDOERFER
Other 510(k) Applications for this Contact
Regulation Number
876.4300
More FDA Info for this Regulation Number
Classification Product Code
KNS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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