FDA 510(k) Application Details - K070520

Device Classification Name

  More FDA Info for this Device
510(K) Number K070520
Device Name PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES)
Applicant BIOLIFE, LLC
1235 TALLEVAST RD.
SARASOTA, FL 34243-3271 US
Other 510(k) Applications for this Company
Contact Karen O'Toole
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 02/23/2007
Decision Date 10/23/2007
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