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510(k) K040591

DUET SYSTEM by Bioview , Ltd. — Product Code JOY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2004
Date Received
March 8, 2004
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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