FDA 510(k) Application Details - K052992

Device Classification Name Wrap, Sterilization

  More FDA Info for this Device
510(K) Number K052992
Device Name Wrap, Sterilization
Applicant CONMED LINVATEC
11311 CONCEPT BOULEVARD
LARGO, FL 33773-4908 US
Other 510(k) Applications for this Company
Contact ELIZABETH PAUL
Other 510(k) Applications for this Contact
Regulation Number 880.6850

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

  More FDA Info for this Product Code
Date Received 10/25/2005
Decision Date 10/16/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
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