FDA 510(k) Application Details - K970013

Device Classification Name Pin, Fixation, Smooth

  More FDA Info for this Device
510(K) Number K970013
Device Name Pin, Fixation, Smooth
Applicant AAP GMBH AND CO. BETRIEBS KG
LORENZWEG 5
12099 BERLIN D-1000 DE
Other 510(k) Applications for this Company
Contact DIPL.-ING CHRISTIAN ABEL
Other 510(k) Applications for this Contact
Regulation Number 888.3040

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

  More FDA Info for this Product Code
Date Received 01/02/1997
Decision Date 03/13/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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