FDA 510(k) Application Details - K970660

Device Classification Name Bandage, Liquid

  More FDA Info for this Device
510(K) Number K970660
Device Name Bandage, Liquid
Applicant DERMA SCIENCES, INC.
15825 SHADY GROVE RD.
ROCKVILLE, MD 20850 US
Other 510(k) Applications for this Company
Contact KENNETH A PALMER, PH.D.
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 02/21/1997
Decision Date 08/12/1997
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