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 Number | 874.3620
|
Classification Product Code |
|
Date Received | 04/11/2016 |
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
|
|
|