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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vibrator For Therapeutic Use, Genital
510(k) Number K010096
Device Name MULTI CARE THERAPEUTIC VIBRATOR
Applicant
Multicept A/S
Lyngsoe Alle 3,1
Hoersholm,  DK 2970
Applicant Contact KLAUS VAMMEN
Correspondent
Multicept A/S
Lyngsoe Alle 3,1
Hoersholm,  DK 2970
Correspondent Contact KLAUS VAMMEN
Regulation Number884.5960
Classification Product Code
KXQ  
Date Received01/11/2001
Decision Date 03/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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