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510(k) K122945

STERITEC GREEN CARD PACK BOWIE-DICK TEST MODEL BD 126 by Steritec Products Mfg Co, Inc. — Product Code JOJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2013
Date Received
September 24, 2012
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

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