BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K002741
Device Name BROWNE TST SINGLE USE BOWIE DICK/INTEGRATOR TEST PACK
Original Applicant
ALBERT BROWNE LTD.
49 plain st.
north attleboro, 
MA 
02760

Original Contact cynthia j.m.nolte
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 09/01/2000
Decision Date 07/03/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No