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510(k) K052797

LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM by Medtek Devices, Inc. — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2006
Date Received
October 3, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

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