The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Model 1712 Catheter Withdrawal Sys For Urethral Pr.
Device ID | K850601 |
510k Number | K850601 |
Device Name: | MODEL 1712 CATHETER WITHDRAWAL SYS FOR URETHRAL PR |
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 | 1985-02-15 |
Decision Date | 1985-04-25 |