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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lubricant, personal
510(k) Number K140506
Device Name JOY DROPS (TM) NATURAL PERSONAL LUBRICANT GEL
Applicant
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA
2237 CHESTNUT STREET
SAN FRANCISCO,  CA  94123
Applicant Contact MICHAEL SCOTT
Correspondent
TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASA
2237 CHESTNUT STREET
SAN FRANCISCO,  CA  94123
Correspondent Contact MICHAEL SCOTT
Regulation Number884.5300
Classification Product Code
NUC  
Date Received02/27/2014
Decision Date 04/17/2015
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
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