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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tampon, Menstrual, Unscented
510(k) Number K090819
Device Name ONTEX TAMPON (UNSCENTED)
Applicant
ONTEX INTERNATIONAL NV
1705 S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN,  TX  78746
Applicant Contact NEAL KOBER
Correspondent
ONTEX INTERNATIONAL NV
1705 S. CAPITAL OF TEXAS HWY
SUITE 500
AUSTIN,  TX  78746
Correspondent Contact NEAL KOBER
Regulation Number884.5470
Classification Product Code
HEB  
Date Received03/25/2009
Decision Date 12/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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