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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name condom
510(k) Number K013086
Device Name WET LIGHT PERSONAL MOISTURIZER
Applicant
TRIGG LABORATORIES, INC.
WARNER CENTER PLAZA
21800 OXNARD STREET, SUITE 840
WOODLAND HILLS,  CA  91367
Applicant Contact W. PATRICK NOONAN
Correspondent
TRIGG LABORATORIES, INC.
WARNER CENTER PLAZA
21800 OXNARD STREET, SUITE 840
WOODLAND HILLS,  CA  91367
Correspondent Contact W. PATRICK NOONAN
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/14/2001
Decision Date 12/13/2001
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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