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FDA 510(k) Application Details - K990687
Device Classification Name
More FDA Info for this Device
510(K) Number
K990687
Device Name
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS
Applicant
OLYMPUS OPTICAL, CO.
2 CORPORATE CENTER
MELVILLE, NY 11747 US
Other 510(k) Applications for this Company
Contact
LAURA STORMS TYLER
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PKL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/01/1999
Decision Date
03/26/1999
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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