Device Classification Name |
tampon, menstrual, unscented
|
510(k) Number |
K180850 |
Device Name |
re.t.a Reuseable Tampon Applicator |
Applicant |
Thinx, Inc. |
601 W 26th Street, Suite 515 |
New York,
NY
10001
|
|
Applicant Contact |
Kerrie Timmons |
Correspondent |
Clover Medical, LLC |
79 Haven St. |
Dover,
MA
02030
|
|
Correspondent Contact |
John Gillespie |
Regulation Number | 884.5470
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/02/2018 |
Decision Date | 08/20/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|