FDA 510(k) Application Details - K082720

Device Classification Name Bronchoscope (Flexible Or Rigid)

  More FDA Info for this Device
510(K) Number K082720
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 STACY ABBATIELLO KLUESNER
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 09/17/2008
Decision Date 11/05/2008
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