Device Classification Name |
Tampon, Menstrual, Unscented
|
510(k) Number |
K212304 |
Device Name |
Callaly Tampliner (super plus absorbency) |
Applicant |
Calla Lily Personal Care, Ltd. |
10 Rose & Crown Yard |
London,
GB
SW1Y 6RE
|
|
Applicant Contact |
Shaun Knights |
Correspondent |
2Harris Consulting, Ltd. |
129 Blore Heath |
Market Drayton,
GB
TF9 2EG
|
|
Correspondent Contact |
Kathleen Harris |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 07/23/2021 |
Decision Date | 08/19/2021 |
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
|
|
|