The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Disposable Urodynamic Catheter Set.
| Device ID | K896784 |
| 510k Number | K896784 |
| Device Name: | DISPOSABLE URODYNAMIC CATHETER SET |
| Classification | Catheter, Urological |
| Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Contact | Coats, M.d. |
| Correspondent | Coats, M.d. LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-04 |
| Decision Date | 1990-02-16 |