VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR


Device Classification Name

indicator, biological sterilization process

510(k) Number K051056
Device Name VERIFY SELF-CONTAINED BIOLOGICAL 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
FRC  
Date Received 04/26/2005
Decision Date 10/20/2005
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