Device Classification Name |
tampon, menstrual, unscented
|
510(k) Number |
K220238 |
Device Name |
Cohitech Cottonlock Tampons with Reusable Applicator |
Applicant |
Cotton High Tech, S.L. |
Colonia La Rabeia, S/N |
Balsareny,
ES
08660
|
|
Applicant Contact |
Anna Garcia Llado |
Correspondent |
Cotton High Tech, S.L. |
Colonia La Rabeia, S/N |
Balsareny,
ES
08660
|
|
Correspondent Contact |
Anna Garcia Llado |
Regulation Number | 884.5470
|
Classification Product Code |
|
Date Received | 01/28/2022 |
Decision Date | 02/25/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|