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510(k) K061602

DUET SYSTEM by Bioview , Ltd. — Product Code JOY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2007
Date Received
June 8, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Automated Cell-Locating
Device Class
Class II
Regulation Number
864.5260
Review Panel
HE
Submission Type

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