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 polymer, ent synthetic-polyamide (mesh or foil material)
510(k) Number K161000
Device Name Biodesign Otologic Repair Graft
Applicant
COOK BIOTECH INCORPORATED
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47909
Applicant Contact PERRY W. GUINN
Correspondent
COOK BIOTECH INCORPORATED
1425 INNOVATION PLACE
WEST LAFAYETTE,  IN  47906
Correspondent Contact KATIE MOLLAND
Regulation Number874.3620
Classification Product Code
KHJ  
Date Received04/11/2016
Decision Date 05/11/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-