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FDA 510(k) Application Details - K023004
Device Classification Name
Nasopharyngoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K023004
Device Name
Nasopharyngoscope (Flexible Or Rigid)
Applicant
ASTRALITE CORP.
7701 WOODLEY AVE.
VAN NUYS, CA 91406 US
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Contact
DORIAN SWARTZ
Other 510(k) Applications for this Contact
Regulation Number
874.4760
More FDA Info for this Regulation Number
Classification Product Code
EOB
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More FDA Info for this Product Code
Date Received
09/09/2002
Decision Date
01/28/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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