FDA 510(k) Application Details - K954483

Device Classification Name Blade, Saw, General & Plastic Surgery, Surgical

  More FDA Info for this Device
510(K) Number K954483
Device Name Blade, Saw, General & Plastic Surgery, Surgical
Applicant STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001 US
Other 510(k) Applications for this Company
Contact TAMMY LOUNDS
Other 510(k) Applications for this Contact
Regulation Number 878.4820

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

  More FDA Info for this Product Code
Date Received 09/27/1995
Decision Date 01/30/1996
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