FDA 510(k) Application Details - K971481

Device Classification Name Prosthesis, Nose, Internal

  More FDA Info for this Device
510(K) Number K971481
Device Name Prosthesis, Nose, Internal
Applicant ALLIED BIOMEDICAL CORP.
3850 RAMADA DR., SUITE C-2
PASO ROBLES, CA 93446 US
Other 510(k) Applications for this Company
Contact GERALD HANSON
Other 510(k) Applications for this Contact
Regulation Number 878.3680

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

  More FDA Info for this Product Code
Date Received 04/23/1997
Decision Date 07/18/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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