FDA 510(k) Application Details - K110732

Device Classification Name Dressing, Wound, Drug

  More FDA Info for this Device
510(K) Number K110732
Device Name Dressing, Wound, Drug
Applicant PRUGEN IP HOLDINGS, INC
8711 E PINNACLE PEAK ROAD
SUITE C-201, PMB 225
SCOTTSDALE, AZ 85255 US
Other 510(k) Applications for this Company
Contact ROBERT L KNECHTEL
Other 510(k) Applications for this Contact
Regulation Number 000.0000

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

  More FDA Info for this Product Code
Date Received 03/16/2011
Decision Date 06/03/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
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