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510(k) K001590

DND 101 by Urogyn , Ltd. — Product Code KNA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2000
Date Received
May 17, 2000
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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