Callaly Tampliner (super Plus Absorbency)

Tampon, Menstrual, Unscented

Calla Lily Personal Care, Ltd.

The following data is part of a premarket notification filed by Calla Lily Personal Care, Ltd. with the FDA for Callaly Tampliner (super Plus Absorbency).

Pre-market Notification Details

Device IDK212304
510k NumberK212304
Device Name:Callaly Tampliner (super Plus Absorbency)
ClassificationTampon, Menstrual, Unscented
Applicant Calla Lily Personal Care, Ltd. 10 Rose & Crown Yard London,  GB Sw1y 6re
ContactShaun Knights
CorrespondentKathleen Harris
2Harris Consulting, Ltd. 129 Blore Heath Market Drayton,  GB Tf9 2eg
Product CodeHEB  
CFR Regulation Number884.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-23
Decision Date2021-08-19

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