The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Multiple, Ent Chair #418.
Device ID | K822530 |
510k Number | K822530 |
Device Name: | MULTIPLE, ENT CHAIR #418 |
Classification | Unit, Examining/treatment, Ent |
Applicant | MIDMARK CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | ETF |
CFR Regulation Number | 874.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-23 |
Decision Date | 1982-09-14 |