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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 K211469
Device Name Callaly Tampliner
Calla Lily Personal Care, Ltd.
10 Rose & Crown Yard
London,  GB SW1Y 6RE
Applicant Contact Shaun Knights
2Harris Consulting, Ltd.
129 Blore Heath
Market Drayton,  GB TF9 2EG
Correspondent Contact Kathleen Harris
Regulation Number884.5470
Classification Product Code
Date Received05/11/2021
Decision Date 06/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No