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
510(k) Number K081272
Device Name PORCINE SURGICAL MESH; DERMAL MATRIX
Applicant
Brennen Medical, LLC
1290 Hammond Rd.
St, Paul,  MN  55110
Applicant Contact KENNETH B HERLAND
Correspondent
Brennen Medical, LLC
1290 Hammond Rd.
St, Paul,  MN  55110
Correspondent Contact KENNETH B HERLAND
Regulation Number878.3300
Classification Product Code
FTM  
Date Received05/05/2008
Decision Date 07/31/2008
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 Yes
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-