510(k) K001649

STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 by Steritec Products, Inc. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2000
Date Received
May 30, 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