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510(k) K063786

ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2 by Olympus Medical Systems Corporation — Product Code FCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2007
Date Received
December 21, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Automatic Carbon-Dioxide For Endoscope
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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