The following data is part of a premarket notification filed by Life-tech Intl., Inc. with the FDA for Ms-iii Ministim.
Device ID | K913184 |
510k Number | K913184 |
Device Name: | MS-III MINISTIM |
Classification | Stimulator, Nerve, Battery-powered |
Applicant | LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
Contact | Alfred C Coats |
Correspondent | Alfred C Coats LIFE-TECH INTL., INC. P.O. BOX 36221 Houston, TX 77236 -6221 |
Product Code | BXN |
CFR Regulation Number | 868.2775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-18 |
Decision Date | 1991-10-07 |