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510(k) K172663

Cytology Brush by Micro-Tech (Nanjing) Co., Ltd. — Product Code FDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2018
Date Received
September 5, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Cytology Brush
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To collect cells for cytological evaluation.

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