FDA 510(k) Application Details - K990875

Device Classification Name Dressing, Wound And Burn, Occlusive

  More FDA Info for this Device
510(K) Number K990875
Device Name Dressing, Wound And Burn, Occlusive
Applicant DERMAPHYLYX, INC.
12106, WEST 75TH LN.
ARVADA, CO 80005-5306 US
Other 510(k) Applications for this Company
Contact ANDREW M REED
Other 510(k) Applications for this Contact
Regulation Number 000.0000

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

  More FDA Info for this Product Code
Date Received 03/16/1999
Decision Date 05/27/1999
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