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510(k) K080410

KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 by KARL STORZ Endoscopy-America, Inc. — Product Code ODA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2008
Date Received
February 14, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Central Control Unit
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To control endoscopic and other ancillary surgical equipment in one central location, either by remote control, touch screen, or voice command.

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