ALIBI BIOLOGICAL INDICATOR, MODEL WS


Device Classification Name

indicator, biological sterilization process

510(k) Number K024079
Device Name ALIBI BIOLOGICAL INDICATOR, MODEL WS
Original Applicant
ARDEN LABORATORIES, INCORPORATED
468b stillwater rd.
willernie, 
MN 
55090 -0687

Original Contact angelea strantz
Regulation Number 880.2800
Classification Product Code
FRC  
Date Received 12/10/2002
Decision Date 02/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No