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
Other 510(k) Applications for this Company
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
Other 510(k) Applications for this Device

  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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact