The following data is part of a premarket notification filed by G. Dundas Co. with the FDA for Model 5460 + 5480 Pop-off Valves.
Device ID | K802591 |
510k Number | K802591 |
Device Name: | MODEL 5460 + 5480 POP-OFF VALVES |
Classification | Gas-machine, Anesthesia |
Applicant | G. DUNDAS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BSZ |
CFR Regulation Number | 868.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-21 |
Decision Date | 1980-11-12 |