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510(k) K171956

Sterile Endoscope Biopsy Sampling Needle by Changzhou Detain Medical Devices Co., Ltd. — Product Code FCG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2017
Date Received
June 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biopsy Needle
Device Class
Class II
Regulation Number
876.1075
Review Panel
GU
Submission Type

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