510(k) K993804

KSEA RIGID CULDOSCOPE AND ACCESSORIES by KARL STORZ Endoscopy-America, Inc. — Product Code HEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2000
Date Received
November 9, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culdoscope (And Accessories)
Device Class
Class II
Regulation Number
884.1640
Review Panel
OB
Submission Type