The following data is part of a premarket notification filed by Rael, Inc. with the FDA for Rael Tampon.
| Device ID | K182814 |
| 510k Number | K182814 |
| Device Name: | Rael Tampon |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | Rael, Inc. 6940 Beach Blvd D-608 & 609 Buena Park, CA 90621 |
| Contact | Binna Won |
| Correspondent | Joyce Kwun Provision Consulting Group, Inc. 3350 Shelby St. Ste 200 Ontario, CA 91764 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-03 |
| Decision Date | 2019-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856032008442 | K182814 | 000 |