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510(k) K960441

STERITEC INTEGRAPH MODEL CI-101 by Steritec Products Mfg Co, Inc. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1997
Date Received
February 1, 1996
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

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