The following data is part of a premarket notification filed by Cotton High Tech Sl with the FDA for Maxim Menstrual Tampons & Organyc Menstrual Tampons.
| Device ID | K091084 |
| 510k Number | K091084 |
| Device Name: | MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | COTTON HIGH TECH SL CTRA NAVAS A PRATS DE LLUCANES KM 1,5 GAIA Barcelona, ES 08679 |
| Contact | Elena Gomez |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-04-15 |
| Decision Date | 2009-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628942539299 | K091084 | 000 |
| 00990498500222 | K091084 | 000 |
| 00990498500215 | K091084 | 000 |
| 00628942539305 | K091084 | 000 |
| 00628719704639 | K091084 | 000 |
| 00628719704134 | K091084 | 000 |
| 00628719704127 | K091084 | 000 |
| 00628719704073 | K091084 | 000 |
| 00810152230848 | K091084 | 000 |