The following data is part of a premarket notification filed by Mission Dental, Inc. with the FDA for Comfort Cushion Dispos. Analgesis.
Device ID | K832752 |
510k Number | K832752 |
Device Name: | COMFORT CUSHION DISPOS. ANALGESIS |
Classification | Apparatus, Gas-scavenging |
Applicant | MISSION DENTAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CBN |
CFR Regulation Number | 868.5430 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-15 |
Decision Date | 1983-12-08 |