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510(k) K100852

STRYKER SWITCHPOINT INFINITY 3 CONTROL SYSTEM, MODEL: 067-8001-000 by Stryker Communications — Product Code OCS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 6, 2010
Date Received: March 26, 2010
Clearance Type: Traditional
Expedited Review: No
Third Party Review: Yes

Device Classification

Device Name: Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device Class: Class II
Regulation Number: 876.1500
Review Panel: GU
Submission Type

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.