The following data is part of a premarket notification filed by Midwest with the FDA for Midwest 1000.
Device ID | K790113 |
510k Number | K790113 |
Device Name: | MIDWEST 1000 |
Classification | Handpiece, Air-powered, Dental |
Applicant | MIDWEST 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-19 |
Decision Date | 1979-02-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MIDWEST 1000 73219268 1139861 Dead/Cancelled |
American Hospital Supply Corporation 1979-06-11 |