The following data is part of a premarket notification filed by Maxim Hygiene Products, Inc. with the FDA for Maxim Hygiene Organically Grown Cotton Tampon.
| Device ID | K090098 |
| 510k Number | K090098 |
| Device Name: | MAXIM HYGIENE ORGANICALLY GROWN COTTON TAMPON |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | MAXIM HYGIENE PRODUCTS, INC. 1468 HARWELL AVE. Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-01-15 |
| Decision Date | 2009-01-30 |
| Summary: | summary |