BROWNE CIDEX OPA INDICATOR


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K991709
Device Name BROWNE CIDEX OPA INDICATOR
Applicant
ALBERT BROWNE LTD.
49 plain st.
north attleboro, 
MA 
02760

Applicant Contact cynthia j.m. nolte
Correspondent
ALBERT BROWNE LTD.
49 plain st.
north attleboro, 
MA 
02760

Correspodent Contact cynthia j.m. nolte
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 05/19/1999
Decision Date 10/08/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls