FDA 510(k) Application Details - K970693

Device Classification Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

  More FDA Info for this Device
510(K) Number K970693
Device Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant ACRYMED, INC.
12232 S.W. GARDEN PL.
PORTLAND, OR 97223 US
Other 510(k) Applications for this Company
Contact BRUCE GIBBINS
Other 510(k) Applications for this Contact
Regulation Number 000.0000

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

  More FDA Info for this Product Code
Date Received 02/25/1997
Decision Date 03/21/1997
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee -
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