FDA 510(k) Application Details - K082554

Device Classification Name Wrap, Sterilization

  More FDA Info for this Device
510(K) Number K082554
Device Name Wrap, Sterilization
Applicant KIMBERLY-CLARK CORP.
172 CONDUCTOR DRIVE
DAWSONVILLE, GA 30534 US
Other 510(k) Applications for this Company
Contact LISA PEACOCK
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 09/03/2008
Decision Date 05/01/2009
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