The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Model Dmc-75 Mini-catheter Set.
| Device ID | K874307 |
| 510k Number | K874307 |
| Device Name: | MODEL DMC-75 MINI-CATHETER SET |
| Classification | Set, Administration, Intravascular |
| Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Contact | Alfred C Coats,m.d. |
| Correspondent | Alfred C Coats,m.d. LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-20 |
| Decision Date | 1988-01-29 |