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510(k) K943801

URIGLOW TRANSILLUMINATING URETERIC STENT MODEL by Rocket of London, Ltd. — Product Code FCS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1995
Date Received
August 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Catheter, Fiberoptic, Glass, Ureteral
Device Class
Class II
Regulation Number
876.4020
Review Panel
GU
Submission Type

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