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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
Contact robert j staab
Regulation Number884.5470
Classification Product Code
HEB  
Date Received08/27/2012
Decision Date 12/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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