BIODESIGN ENT REPAIR GRAFT


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

Correspodent Contact mary a faderan, ph.d., rac
Regulation Number 874.3620
Classification Product Code
KHJ  
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

Category: Uncategorized