The following data is part of a premarket notification filed by Cycle, Llc with the FDA for Every Cycle Reusable Tampon Applicator.
| Device ID | K211519 |
| 510k Number | K211519 |
| Device Name: | Every Cycle Reusable Tampon Applicator |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | Cycle, LLC 1927 Washington Avenue Santa Monica, CA 90403 |
| Contact | Jessica Samson |
| Correspondent | Gabriela Mccoole NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-17 |
| Decision Date | 2021-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860007113727 | K211519 | 000 |