EXAMINATION LAMP

Device, Medical Examination, Ac Powered

AIR-SHIELDS, INC.

The following data is part of a premarket notification filed by Air-shields, Inc. with the FDA for Examination Lamp.

Pre-market Notification Details

Device IDK922150
510k NumberK922150
Device Name:EXAMINATION LAMP
ClassificationDevice, Medical Examination, Ac Powered
Applicant AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro,  PA  19040
ContactFrancis X Casey
CorrespondentFrancis X Casey
AIR-SHIELDS, INC. 330 JACKSONVILLE RD. Hatboro,  PA  19040
Product CodeKZF  
CFR Regulation Number880.6320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-07
Decision Date1992-07-21

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