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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vaginal
510(k) Number K071754
Device Name NEO-VAGINA SURGERY SET AND ACCESSORIES
Applicant
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pointe
Culver City,  CA  90230 -7600
Applicant Contact CRYSTAL DIZOL
Correspondent
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pointe
Culver City,  CA  90230 -7600
Correspondent Contact CRYSTAL DIZOL
Regulation Number884.3900
Classification Product Code
HDX  
Date Received06/28/2007
Decision Date 01/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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