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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 K955589
Device Name FERTICARE PERSONAL THERAPEUTIC VIBRATOR
Applicant
MULTICEPT APS
VALLERODVANGE 2
2960 RUNGSTED KYST,DENMARK,  DK
Applicant Contact S, K MCGARVEY
Correspondent
MULTICEPT APS
VALLERODVANGE 2
2960 RUNGSTED KYST,DENMARK,  DK
Correspondent Contact S, K MCGARVEY
Regulation Number884.5960
Classification Product Code
KXQ  
Subsequent Product Code
IRO  
Date Received12/07/1995
Decision Date 04/11/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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