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 K160869
Device Name Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft
Applicant
COOK BIOTECH INCORPORATED
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47906
Applicant Contact Perry W. Guinn
Correspondent
COOK BIOTECH INCORPORATED
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47906
Correspondent Contact Nick Wang
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Code
GXQ  
Date Received03/30/2016
Decision Date 04/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-