Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
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 K960219
Device Name PROLEX MESH
Applicant
ADVANCED SURGICAL INNOVATIONS, INC.
6890 PACIFIC CIRCLE
MISSISSAUGA, ONTARIO,  CA L5TIN8
Applicant Contact DAVID M OLSEN
Correspondent
ADVANCED SURGICAL INNOVATIONS, INC.
6890 PACIFIC CIRCLE
MISSISSAUGA, ONTARIO,  CA L5TIN8
Correspondent Contact DAVID M OLSEN
Regulation Number878.3300
Classification Product Code
FTL  
Date Received01/16/1996
Decision Date 03/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-