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510(k) K930348

COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM by Boston Scientific Corp — Product Code FDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1993
Date Received
January 25, 1993
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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