MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS

Device Classification Name

indicator, biological sterilization process

510(k) Number K032914
Device Name MODIFICATION TO:RAVEN BACTERIAL SPORE STRIPS
Applicant
RAVEN BIOLOGICAL LABORATORIES, INC.
8607 park dr.
omaha, 
NE 
68127

Applicant Contact wendy royalty-hann
Correspondent
RAVEN BIOLOGICAL LABORATORIES, INC.
8607 park dr.
omaha, 
NE 
68127

Correspodent Contact wendy royalty-hann
Regulation Number 880.2800
Classification Product Code
FRC  
Date Received 09/22/2003
Decision Date 05/25/2004
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