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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 K122603
Device Name ONTEX AND OTHER PROPRIETARY NAMES
Applicant
ONTEX BVBA
30 NECK ROAD
OLD LYME,  CT  06371
Applicant Contact ROBERT J STAAB
Correspondent
ONTEX BVBA
30 NECK ROAD
OLD LYME,  CT  06371
Correspondent Contact ROBERT J STAAB
Regulation Number884.5470
Classification Product Code
HEB  
Date Received08/27/2012
Decision Date 12/19/2012
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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