GALEMED CPAP MASK

Ventilator, Non-continuous (respirator)

GALEMED CORP.

The following data is part of a premarket notification filed by Galemed Corp. with the FDA for Galemed Cpap Mask.

Pre-market Notification Details

Device IDK072755
510k NumberK072755
Device Name:GALEMED CPAP MASK
ClassificationVentilator, Non-continuous (respirator)
Applicant GALEMED CORP. 3460 POINTE CREEK COURT SUITE 102 Bonita Springs,  FL  34134 -2015
ContactPaul Dryden
CorrespondentPaul Dryden
GALEMED CORP. 3460 POINTE CREEK COURT SUITE 102 Bonita Springs,  FL  34134 -2015
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-27
Decision Date2007-11-16
Summary:summary

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