MODEL 5460 + 5480 POP-OFF VALVES

Gas-machine, Anesthesia

G. DUNDAS CO.

The following data is part of a premarket notification filed by G. Dundas Co. with the FDA for Model 5460 + 5480 Pop-off Valves.

Pre-market Notification Details

Device IDK802591
510k NumberK802591
Device Name:MODEL 5460 + 5480 POP-OFF VALVES
ClassificationGas-machine, Anesthesia
Applicant G. DUNDAS CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeBSZ  
CFR Regulation Number868.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-10-21
Decision Date1980-11-12

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