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510(k) K083295

SERIM DISINTEK GTA 2.1%, MODEL: 5164 by Serim Research Corp. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 2009
Date Received
November 10, 2008
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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