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510(k) K924646

OVER THE GUIDEWIRE DILATATION SYSTEM by Medovations, Inc. — Product Code KNQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1994
Date Received
September 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Esophageal
Device Class
Class II
Regulation Number
876.5365
Review Panel
GU
Submission Type

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