FDA 510(k) Application Details - K033225

Device Classification Name Bronchoscope (Flexible Or Rigid)

  More FDA Info for this Device
510(K) Number K033225
Device Name Bronchoscope (Flexible Or Rigid)
Applicant OLYMPUS OPTICAL CO., LTD.
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-3157 US
Other 510(k) Applications for this Company
Contact TINA STEFFANIE-OAK
Other 510(k) Applications for this Contact
Regulation Number 874.4680

  More FDA Info for this Regulation Number
Classification Product Code EOQ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 10/06/2003
Decision Date 10/16/2003
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 Y
Expedited Review



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