The following data is part of a premarket notification filed by Syn-optics with the FDA for Syn-optics #5200.
Device ID | K820624 |
510k Number | K820624 |
Device Name: | SYN-OPTICS #5200 |
Classification | Endoscopic Video Imaging System/component, Gastroenterology-urology |
Applicant | SYN-OPTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FET |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-03-08 |
Decision Date | 1982-04-01 |