• 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 K973955
Device Name HERNIAMESH SURGICAL MESHES
Applicant
HERNIAMESH
1802 NO. 103 AVE.
OMAHA,  NE  68114
Applicant Contact LORENA A TRABUCCO
Correspondent
HERNIAMESH
1802 NO. 103 AVE.
OMAHA,  NE  68114
Correspondent Contact LORENA A TRABUCCO
Regulation Number878.3300
Classification Product Code
FTL  
Date Received10/16/1997
Decision Date 05/11/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-