FDA 510(k) Application Details - K150801

Device Classification Name Motor, Drill, Pneumatic

  More FDA Info for this Device
510(K) Number K150801
Device Name Motor, Drill, Pneumatic
Applicant STRYKER CORPORATION
4100 E. MILHAM AVENUE
KALAMAZOO, MI 49001 US
Other 510(k) Applications for this Company
Contact DEVAL PATEL
Other 510(k) Applications for this Contact
Regulation Number 882.4370

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

  More FDA Info for this Product Code
Date Received 03/26/2015
Decision Date 05/22/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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