FDA 510(k) Application Details - K982116

Device Classification Name Bandage, Liquid

  More FDA Info for this Device
510(K) Number K982116
Device Name Bandage, Liquid
Applicant CONVATEC, A BRISTOL-MYERS SQUIBB CO.
100 HEADQUARTERS PARK DR.
SKILLMAN, NJ 08558 US
Other 510(k) Applications for this Company
Contact AMEER ALLY
Other 510(k) Applications for this Contact
Regulation Number 880.5090

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

  More FDA Info for this Product Code
Date Received 06/16/1998
Decision Date 09/08/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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