The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Urodynamics Tubing And Infusion Sets.
| Device ID | K954341 |
| 510k Number | K954341 |
| Device Name: | URODYNAMICS TUBING AND INFUSION SETS |
| Classification | Device, Cystometric, Hydraulic |
| Applicant | LIFE-TECH INTL., INC. 10920 KINGHURST Houston, TX 77099 |
| Contact | Alfred C Coats |
| Correspondent | Alfred C Coats LIFE-TECH INTL., INC. 10920 KINGHURST Houston, TX 77099 |
| Product Code | FEN |
| CFR Regulation Number | 876.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-18 |
| Decision Date | 1995-10-17 |