The following data is part of a premarket notification filed by Joseph A. Resnick with the FDA for Speech Teacher.
Device ID | K840112 |
510k Number | K840112 |
Device Name: | SPEECH TEACHER |
Classification | System, Communication, Non-powered |
Applicant | JOSEPH A. RESNICK 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ILP |
CFR Regulation Number | 890.3700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-09 |
Decision Date | 1984-03-22 |