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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 K033776
Device Name INSTEAD INTIMATE LUBRICANT
Applicant
Instead, Inc.
4370 La Jolla Village Dr.
Suite 960
San Diego,  CA  92122
Applicant Contact JOE PIKE
Correspondent
Instead, Inc.
4370 La Jolla Village Dr.
Suite 960
San Diego,  CA  92122
Correspondent Contact JOE PIKE
Regulation Number884.5300
Classification Product Code
NUC  
Date Received12/03/2003
Decision Date 06/25/2004
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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