• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name mesh, surgical, polymeric
510(k) Number K012025
Device Name MACROPORE SURGIWRAP (TS)
Original Applicant
MACROPORE BIOSURGERY, INC.
6740 top gun st.
san diego,  CA  92121
Original Contact kenneth k kleinhenz
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/28/2001
Decision Date 12/03/2001
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-