The following data is part of a premarket notification filed by Bioself, Inc. with the FDA for Bioself Tm 110.
| Device ID | K843699 |
| 510k Number | K843699 |
| Device Name: | BIOSELF TM 110 |
| Classification | Device, Fertility Diagnostic, Proceptive |
| Applicant | BIOSELF, INC. C.P. 70 Saint-lambert, Que. Canad, |
| Contact | Yves Renaud |
| Correspondent | Yves Renaud BIOSELF, INC. C.P. 70 Saint-lambert, Que. Canad, |
| Product Code | LHD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-20 |
| Decision Date | 1984-12-04 |