DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES


Device Classification Name

indicator, biological sterilization process

510(k) Number K103321
Device Name DANA REUSABLE TESTPACK FOR STEAM STERILIZATION FOR 10 MINUTE EXTENDED CYCLES
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
FRC  
Date Received 11/12/2010
Decision Date 02/16/2011
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