FDA 510(k) Application Details - K023635

Device Classification Name Gown, Surgical

  More FDA Info for this Device
510(K) Number K023635
Device Name Gown, Surgical
Applicant SRI/SURGICAL EXPRESS, INC.
12425 RACE TRACK RD.
TAMPA, FL 33626 US
Other 510(k) Applications for this Company
Contact JACK A HAMILTON
Other 510(k) Applications for this Contact
Regulation Number 878.4040

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

  More FDA Info for this Product Code
Date Received 10/29/2002
Decision Date 11/18/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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