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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 K122061
FOIA Releasable 510(k) K122061
Device Name K-Y BRAND LIQUIBEADS
Applicant
JOHNSON & JOHNSON HEALTHCARE PRODUCTS
185 TABOR ROAD
MORRIS PLAINS,  NJ  07950
Applicant Contact LORNA-JANE BREMER
Correspondent
JOHNSON & JOHNSON HEALTHCARE PRODUCTS
185 TABOR ROAD
MORRIS PLAINS,  NJ  07950
Correspondent Contact LORNA-JANE BREMER
Regulation Number884.5300
Classification Product Code
NUC  
Date Received07/13/2012
Decision Date 11/08/2013
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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