PROCHEM INDICATOR TAPE


Device Classification Name

indicator, physical/chemical sterilization process

510(k) Number K080307
Device Name PROCHEM INDICATOR TAPE
Applicant
RAVEN LABORATORIES
8607 park dr.
omaha, 
NE 
68127

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

Correspodent Contact wendy royalty-hann
Regulation Number 880.2800
Classification Product Code
JOJ  
Date Received 02/05/2008
Decision Date 05/01/2008
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