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510(k) K071754

NEO-VAGINA SURGERY SET AND ACCESSORIES by KARL STORZ Endoscopy-America, Inc. — Product Code HDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2009
Date Received
June 28, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Vaginal
Device Class
Class II
Regulation Number
884.3900
Review Panel
OB
Submission Type

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