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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nasopharyngoscope (flexible or rigid)
510(k) Number K023004
Device Name LFRE INDIRECT LARYNGOSCOPE
Applicant
ASTRALITE CORP.
7701 WOODLEY AVE.
VAN NUYS,  CA  91406
Applicant Contact DORIAN SWARTZ
Correspondent
ASTRALITE CORP.
7701 WOODLEY AVE.
VAN NUYS,  CA  91406
Correspondent Contact DORIAN SWARTZ
Regulation Number874.4760
Classification Product Code
EOB  
Date Received09/09/2002
Decision Date 01/28/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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