ALLERGEAZE R CLEAR


Device Classification Name

system, delivery, allergen and vaccine

510(k) Number K103409
Device Name ALLERGEAZE R CLEAR
Applicant
SMARTPRACTICE
3400 east mcdowll road
phoenix, 
AZ 
85008

Applicant Contact kim sullivan
Correspondent
SMARTPRACTICE
3400 east mcdowll road
phoenix, 
AZ 
85008

Correspodent Contact kim sullivan
Classification Product Code
LDH  
Date Received 11/22/2010
Decision Date 03/15/2011
Decision

substantially equivalent

(SESE)

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No