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 K002351
Device Name FLUOROTEX II SURGICAL MESH
Applicant
BRIDGER BIOMED, INC.
2430 NORTH 7TH AVE., SUITE 4
BOZEMAN,  MT  59715
Applicant Contact BRUCE G RUEFER
Correspondent
BRIDGER BIOMED, INC.
2430 NORTH 7TH AVE., SUITE 4
BOZEMAN,  MT  59715
Correspondent Contact BRUCE G RUEFER
Regulation Number878.3300
Classification Product Code
FTL  
Date Received08/02/2000
Decision Date 08/26/2000
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
-
-