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510(k) K992341

CIDEX OPA SOLUTION TEST STRIP by Serim Research Corp. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1999
Date Received
July 13, 1999
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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