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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 K042915
Device Name O'MY NATURAL LUBRICANT, O'MY NATURAL FLAVORED LUBRICANT
Applicant
O'MY PRODUCTS INCORPORATED
188 PEMBERTON AVENUE
NORTH VANCOUVER,  CA V7P 2R5
Applicant Contact ROB LOGAN
Correspondent
O'MY PRODUCTS INCORPORATED
188 PEMBERTON AVENUE
NORTH VANCOUVER,  CA V7P 2R5
Correspondent Contact ROB LOGAN
Regulation Number884.5300
Classification Product Code
NUC  
Date Received10/21/2004
Decision Date 08/31/2005
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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