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FDA 510(k) Application Details - K974168
Device Classification Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
More FDA Info for this Device
510(K) Number
K974168
Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant
HOGAN & HARTSON
555 13TH ST., N.W.
WASHINGTON, DC 20004-1109 US
Other 510(k) Applications for this Company
Contact
JONATHAN S KAHAN
Other 510(k) Applications for this Contact
Regulation Number
876.4300
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Classification Product Code
KNS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/05/1997
Decision Date
01/23/1998
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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