FDA 510(k) Application Details - K013242

Device Classification Name Lamp, Surgical

  More FDA Info for this Device
510(K) Number K013242
Device Name Lamp, Surgical
Applicant STERIS Corporation
2720 GUNTER PARK EAST
MONTGOMERY, AL 36109 US
Other 510(k) Applications for this Company
Contact ROBERT H MCCALL
Other 510(k) Applications for this Contact
Regulation Number 878.4580

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

  More FDA Info for this Product Code
Date Received 09/28/2001
Decision Date 12/13/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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