REUSABLE TEST PACK FOR DANA EMULATING INDICATORS


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K110253
Device Name REUSABLE TEST PACK FOR DANA EMULATING INDICATORS
Applicant
DANA PRODUCTS, INC.
7 corey dr.
south barrington, 
IL 
60010

Applicant Contact harry bala
Correspondent
DANA PRODUCTS, INC.
7 corey dr.
south barrington, 
IL 
60010

Correspodent Contact harry bala
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 01/28/2011
Decision Date 04/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No