The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for 1351 Uroflow Auto Start.
| Device ID | K853936 |
| 510k Number | K853936 |
| Device Name: | 1351 UROFLOW AUTO START |
| Classification | Cystometric Gas (carbon-dioxide) On Hydraulic Device |
| Applicant | LIFE-TECH INTL., INC. 10515 HARWIN DR. P.O.B OX 36221 Houston, TX 77036 |
| Contact | Alfred C Coats |
| Correspondent | Alfred C Coats LIFE-TECH INTL., INC. 10515 HARWIN DR. P.O.B OX 36221 Houston, TX 77036 |
| Product Code | FAP |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-24 |
| Decision Date | 1985-12-02 |