Device Classification Name |
Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
|
510(k) Number |
K121360 |
Device Name |
BIODESIGN ENT REPAIR GRAFT |
Applicant |
COOK BIOTECH INCORPRATED |
1425 INNOVATION PLACE |
WEST LAFAYETTE,
IN
47906 -1000
|
|
Applicant Contact |
MARY A FADERAN, PH.D., RAC |
Correspondent |
COOK BIOTECH INCORPRATED |
1425 INNOVATION PLACE |
WEST LAFAYETTE,
IN
47906 -1000
|
|
Correspondent Contact |
MARY A FADERAN, PH.D., RAC |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 05/07/2012 |
Decision Date | 02/27/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|