DISPOSABLE BERMAN AND GUEDEL AIRWAYS

Airway, Oropharyngeal, Anesthesiology

DRYDEN CORP.

The following data is part of a premarket notification filed by Dryden Corp. with the FDA for Disposable Berman And Guedel Airways.

Pre-market Notification Details

Device IDK861540
510k NumberK861540
Device Name:DISPOSABLE BERMAN AND GUEDEL AIRWAYS
ClassificationAirway, Oropharyngeal, Anesthesiology
Applicant DRYDEN CORP. 10640 EAST 59TH ST. P.O. BOX 36038 Indianapolis,  IN  46236
ContactPaul E Dryden
CorrespondentPaul E Dryden
DRYDEN CORP. 10640 EAST 59TH ST. P.O. BOX 36038 Indianapolis,  IN  46236
Product CodeCAE  
CFR Regulation Number868.5110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-04-24
Decision Date1986-05-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.