MEDI - PUMP

Nebulizer (direct Patient Interface)

THOMAS INDUSTRIES

The following data is part of a premarket notification filed by Thomas Industries with the FDA for Medi - Pump.

Pre-market Notification Details

Device IDK950290
510k NumberK950290
Device Name:MEDI - PUMP
ClassificationNebulizer (direct Patient Interface)
Applicant THOMAS INDUSTRIES 1419 ILLINOIS AVE. Sheboygan,  WI  53082 -0029
ContactDan Pfister
CorrespondentDan Pfister
THOMAS INDUSTRIES 1419 ILLINOIS AVE. Sheboygan,  WI  53082 -0029
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-25
Decision Date1995-08-24

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