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510(k) K014248

DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER by Urogyn , Ltd. — Product Code KNA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2002
Date Received
December 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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