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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Engorgement, Clitoral
510(k) Number K043480
Device Name ENHANCE CLITORAL STIMULATION AID
Applicant
Gynavations, Inc.
665 Salem St.
Malden,  MA  02148
Applicant Contact DAVID GLOTH
Correspondent
Gynavations, Inc.
665 Salem St.
Malden,  MA  02148
Correspondent Contact DAVID GLOTH
Regulation Number884.5970
Classification Product Code
NBV  
Date Received12/16/2004
Decision Date 06/08/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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