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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 K182814
Device Name Rael Tampon
Applicant
Rael, Inc.
6940 Beach Blvd D-608 & 609
Buena Park,  CA  90621
Applicant Contact Binna Won
Correspondent
Provision Consulting Group, Inc.
3350 Shelby St. Ste 200
Ontario,  CA  91764
Correspondent Contact Joyce Kwun
Regulation Number884.5470
Classification Product Code
HEB  
Date Received10/03/2018
Decision Date 07/15/2019
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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