The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Model Sk-14 Starter Kit For Dental Iontophoresis.
Device ID | K872039 |
510k Number | K872039 |
Device Name: | MODEL SK-14 STARTER KIT FOR DENTAL IONTOPHORESIS |
Classification | Tester, Pulp |
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 | EAT |
CFR Regulation Number | 872.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-27 |
Decision Date | 1987-11-13 |