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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 K061466
Device Name INTIMOL
Applicant
Dlc Laboratories, Inc.
7008 Marcelle St.
Paramount,  CA  90723
Applicant Contact JUAN MANZUR
Correspondent
Dlc Laboratories, Inc.
7008 Marcelle St.
Paramount,  CA  90723
Correspondent Contact JUAN MANZUR
Regulation Number884.5300
Classification Product Code
NUC  
Date Received05/26/2006
Decision Date 12/04/2006
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
Predetermined Change
Control Plan Authorized		 No
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