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510(k) K984168

BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE by United States Endoscopy Group, Inc. — Product Code FCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1999
Date Received
November 20, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy, Mechanical, Gastrointestinal
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

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