The following data is part of a premarket notification filed by Scientific Manufacturer with the FDA for Scientronics 10k Eye Magnet.
Device ID | K832950 |
510k Number | K832950 |
Device Name: | SCIENTRONICS 10K EYE MAGNET |
Classification | Magnet, Ac-powered |
Applicant | SCIENTIFIC MANUFACTURER 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HPO |
CFR Regulation Number | 886.4440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-31 |
Decision Date | 1983-10-19 |