510(k) K003533

CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L by Steritec Products, Inc. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2001
Date Received
November 16, 2000
Clearance Type
Abbreviated
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