The following data is part of a premarket notification filed by Midwest Dental Products Corp. with the FDA for Tradition P, Push Button Handpiece.
Device ID | K963050 |
510k Number | K963050 |
Device Name: | TRADITION P, PUSH BUTTON HANDPIECE |
Classification | Handpiece, Air-powered, Dental |
Applicant | MIDWEST DENTAL PRODUCTS CORP. 901 W OAKTON ST. Des Plaines, IL 60018 -1884 |
Contact | Hector Jimenez-billini |
Correspondent | Hector Jimenez-billini MIDWEST DENTAL PRODUCTS CORP. 901 W OAKTON ST. Des Plaines, IL 60018 -1884 |
Product Code | EFB |
CFR Regulation Number | 872.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-06 |
Decision Date | 1996-10-11 |