DISPOSABLE BERMAN AIRWAYS

Airway, Oropharyngeal, Anesthesiology

HARVARD LABORATORIES

The following data is part of a premarket notification filed by Harvard Laboratories with the FDA for Disposable Berman Airways.

Pre-market Notification Details

Device IDK800881
510k NumberK800881
Device Name:DISPOSABLE BERMAN AIRWAYS
ClassificationAirway, Oropharyngeal, Anesthesiology
Applicant HARVARD LABORATORIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCAE  
CFR Regulation Number868.5110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-04-17
Decision Date1980-05-08

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