510(k) K770078

CASTLE TEC-TEST STEAM STERI. INTEGRATOR by Castle Co. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1977
Date Received
January 13, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Physical/Chemical Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type