The following data is part of a premarket notification filed by Thinx, Inc. with the FDA for Re.t.a Reuseable Tampon Applicator.
| Device ID | K180850 |
| 510k Number | K180850 |
| Device Name: | Re.t.a Reuseable Tampon Applicator |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | Thinx, Inc. 601 W 26th Street, Suite 515 New York, NY 10001 |
| Contact | Kerrie Timmons |
| Correspondent | John Gillespie Clover Medical, LLC 79 Haven St. Dover, MA 02030 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-02 |
| Decision Date | 2018-08-20 |
| Summary: | summary |