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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 K012203
Device Name CLAY-PARK LABS, INC. - LUBRICATING JELLY
Applicant
CLAY-PARK LABS, INC.
1800 MASSACHUSETTS AVE., N.W.
WASHINGTON,  DC  20036
Applicant Contact GARY L YINGLING
Correspondent
CLAY-PARK LABS, INC.
1800 MASSACHUSETTS AVE., N.W.
WASHINGTON,  DC  20036
Correspondent Contact GARY L YINGLING
Regulation Number884.5300
Classification Product Code
NUC  
Date Received07/13/2001
Decision Date 08/27/2001
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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