The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Urolab Janus.
| Device ID | K904386 |
| 510k Number | K904386 |
| Device Name: | UROLAB JANUS |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Contact | Alfred Coats |
| Correspondent | Alfred Coats LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-24 |
| Decision Date | 1990-11-27 |