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 |