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510(k) K020255

RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590 by Richard Wolf Medical Instruments Corp. — Product Code ODA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2002
Date Received
January 24, 2002
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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