MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL


Device Classification Name

polymer, ear, nose and throat, synthetic, absorbable

510(k) Number K122434
Device Name MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL
Applicant
MEDTRONIC XOMED
6743 southpoint dr. north
jacksonville, 
FL 
32216

Applicant Contact antoine kouchakjy
Correspondent
MEDTRONIC XOMED
6743 southpoint dr. north
jacksonville, 
FL 
32216

Correspodent Contact antoine kouchakjy
Regulation Number 874.3620
Classification Product Code
NHB  
Date Received 08/10/2012
Decision Date 10/31/2012
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