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510(k) K163495

AdvanCE capsule endoscope delivery device by United States Endoscopy Group, Inc. — Product Code NEZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2017
Date Received
December 13, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Gastrointestinal, Wireless, Capsule
Device Class
Class II
Regulation Number
876.1300
Review Panel
GU
Submission Type

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