The following data is part of a premarket notification filed by Bio Business Intl, Inc. with the FDA for Terra Femme.
| Device ID | K930400 |
| 510k Number | K930400 |
| Device Name: | TERRA FEMME |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | BIO BUSINESS INTL, INC. 152 LAMBERTLODGE AVENUE Canada M6g 3x3, CA |
| Contact | Wilhelmina Nolan |
| Correspondent | Wilhelmina Nolan BIO BUSINESS INTL, INC. 152 LAMBERTLODGE AVENUE Canada M6g 3x3, CA |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-26 |
| Decision Date | 1994-03-14 |