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510(k) K042665

SMART BITEBLOC by Oridion Medical 1987 , Ltd. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2004
Date Received
September 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

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