PREFILLED NEBULIZER

Nebulizer (direct Patient Interface)

CORPAK CO.

The following data is part of a premarket notification filed by Corpak Co. with the FDA for Prefilled Nebulizer.

Pre-market Notification Details

Device IDK810218
510k NumberK810218
Device Name:PREFILLED NEBULIZER
ClassificationNebulizer (direct Patient Interface)
Applicant CORPAK CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-01-27
Decision Date1981-03-04

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