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510(k) K091617

QMS LIDOCAINE CALIBRATORS, MODEL 0374678 by Thermo Fisher Scientific — Product Code DLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2009
Date Received
June 3, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Specific
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

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