GENUINE FIRST AID CPR MASK

Valve, Non-rebreathing

GENUINE FIRST AID LLC

The following data is part of a premarket notification filed by Genuine First Aid Llc with the FDA for Genuine First Aid Cpr Mask.

Pre-market Notification Details

Device IDK112126
510k NumberK112126
Device Name:GENUINE FIRST AID CPR MASK
ClassificationValve, Non-rebreathing
Applicant GENUINE FIRST AID LLC 150 CHERRY LANE RD. East Stroudsburg,  PA  18301
ContactGary Lehnus
CorrespondentGary Lehnus
GENUINE FIRST AID LLC 150 CHERRY LANE RD. East Stroudsburg,  PA  18301
Product CodeCBP  
CFR Regulation Number868.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-25
Decision Date2011-12-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00347682802011 K112126 000
50347682802108 K112126 000
06970529420013 K112126 000

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