FDA 510(k) Application Details - K121186

Device Classification Name Forceps, Biopsy, Bronchoscope (Non-Rigid)

  More FDA Info for this Device
510(K) Number K121186
Device Name Forceps, Biopsy, Bronchoscope (Non-Rigid)
Applicant BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
Other 510(k) Applications for this Company
Contact CORRIE GOODING
Other 510(k) Applications for this Contact
Regulation Number 874.4680

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

  More FDA Info for this Product Code
Date Received 04/18/2012
Decision Date 05/16/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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