The following data is part of a premarket notification filed by Medical Magnetics, Inc. with the FDA for Orthomag Magnetic Force System.
Device ID | K843550 |
510k Number | K843550 |
Device Name: | ORTHOMAG MAGNETIC FORCE SYSTEM |
Classification | Spring, Orthodontic |
Applicant | MEDICAL MAGNETICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Contact | Abraham B Blechman |
Correspondent | Abraham B Blechman MEDICAL MAGNETICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ECO |
CFR Regulation Number | 872.5410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-10 |
Decision Date | 1984-12-21 |