The following data is part of a premarket notification filed by Sybron Corp. with the FDA for Sybron/kerr Mirror 3.
Device ID | K820183 |
510k Number | K820183 |
Device Name: | SYBRON/KERR MIRROR 3 |
Classification | Material, Impression |
Applicant | SYBRON CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | ELW |
CFR Regulation Number | 872.3660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-22 |
Decision Date | 1982-02-24 |