FDA 510(k) Application Details - K971091

Device Classification Name Bandage, Liquid

  More FDA Info for this Device
510(K) Number K971091
Device Name Bandage, Liquid
Applicant OPPORTUNITY, INC.
1200 OLD SKOKIE RD.
HIGHLAND PARK, IL 60035 US
Other 510(k) Applications for this Company
Contact JAMES S SANDERS
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 03/24/1997
Decision Date 09/16/1997
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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