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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 K040428
Device Name MULTIPLE EROZONE BODYGLIDE FLUID, EROZONE BODYGLIDE GEL, EROZONE LATEX DRESSING, EROZONE BODYGLIDE NATURAL FOAM
Applicant
R & K INTERNATIONAL COSMETICS
1020 19TH STREET NW
SUITE 400
WASHINGTON,  DC  20036
Applicant Contact GARYN L LOTRIDGE
Correspondent
R & K INTERNATIONAL COSMETICS
1020 19TH STREET NW
SUITE 400
WASHINGTON,  DC  20036
Correspondent Contact GARYN L LOTRIDGE
Regulation Number884.5300
Classification Product Code
NUC  
Date Received02/19/2004
Decision Date 08/09/2005
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
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