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510(k) K162332

Nexcore GI Insufflator by Nexcore Technology, LLC — Product Code FCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2016
Date Received
August 19, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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