FDA 510(k) Application Details - K983368

Device Classification Name Tape And Bandage, Adhesive

  More FDA Info for this Device
510(K) Number K983368
Device Name Tape And Bandage, Adhesive
Applicant ASO CORP.
300 SARASOTA CENTER BLVD.
SARASOTA, FL 34240 US
Other 510(k) Applications for this Company
Contact JOAN RUBENDALL
Other 510(k) Applications for this Contact
Regulation Number 880.5240

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

  More FDA Info for this Product Code
Date Received 09/24/1998
Decision Date 02/17/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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