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510(k) K100551

ORLOCATE SYSTEM MODEL ORL 100 by Haldor Advanced Technologies, Ltd. — Product Code LWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2010
Date Received
February 26, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Sponge, Surgical
Device Class
Class I
Regulation Number
880.2740
Review Panel
SU
Submission Type

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