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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 K201003
Device Name Callaly Tampliner
Applicant
Calla Lily Personal Care, Ltd.
10 Rose & Crown Yard
London,  GB SW1Y 6RE
Applicant Contact Shaun Knights
Correspondent
2Harris Consulting
129 Blore Heath
Market Drayton,  GB TF9 2EG
Correspondent Contact Kathleen Harris
Regulation Number884.5470
Classification Product Code
HEB  
Date Received04/16/2020
Decision Date 12/07/2020
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
Predetermined Change
Control Plan Authorized		 No
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