The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Modified Use For Model 6110a Iontophoretic Appli..
Device ID | K871869 |
510k Number | K871869 |
Device Name: | MODIFIED USE FOR MODEL 6110A IONTOPHORETIC APPLI. |
Classification | Device, Iontophoresis, Other Uses |
Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
Contact | Coats, Md |
Correspondent | Coats, Md LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
Product Code | EGJ |
CFR Regulation Number | 890.5525 [🔎] |
Decision | Substantially Equivalent - With Drug (SESD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-05-13 |
Decision Date | 1987-08-11 |