FDA 510(k) Application Details - K061313

Device Classification Name Bronchoscope (Flexible Or Rigid)

  More FDA Info for this Device
510(K) Number K061313
Device Name Bronchoscope (Flexible Or Rigid)
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLEY, PA 18034-0610 US
Other 510(k) Applications for this Company
Contact LAURA STORMS-TYLER
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 05/10/2006
Decision Date 08/31/2006
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