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510(k) K100345

SYSTEMS INTEGRATION MODEL: ENDOALPHA by Olympus Medical Systems Corporation — Product Code ODA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2010
Date Received
February 5, 2010
Clearance Type
Special
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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