The following data is part of a premarket notification filed by Sybron Corp. with the FDA for Panoramic X-ray System Model A.
Device ID | K772164 |
510k Number | K772164 |
Device Name: | PANORAMIC X-RAY SYSTEM MODEL A |
Classification | Unit, X-ray, Extraoral With Timer |
Applicant | SYBRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EHD |
CFR Regulation Number | 872.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-11-17 |
Decision Date | 1977-12-02 |