NON-REUSABLE UNIVERSAL NEBULIZER FILTE

Filter, Bacterial, Breathing-circuit

OHIO MEDICAL PRODUCTS

The following data is part of a premarket notification filed by Ohio Medical Products with the FDA for Non-reusable Universal Nebulizer Filte.

Pre-market Notification Details

Device IDK823257
510k NumberK823257
Device Name:NON-REUSABLE UNIVERSAL NEBULIZER FILTE
ClassificationFilter, Bacterial, Breathing-circuit
Applicant OHIO MEDICAL PRODUCTS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCAH  
CFR Regulation Number868.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-11-01
Decision Date1982-12-09

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