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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Exhaust, Surgical
510(k) Number K052797
Device Name LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM
Applicant
Medtek Devices, Inc.
595 Commerce Dr.
Buffalo,  NY  14228
Applicant Contact ROBERT O DEAN
Correspondent
Medtek Devices, Inc.
595 Commerce Dr.
Buffalo,  NY  14228
Correspondent Contact ROBERT O DEAN
Regulation Number878.5070
Classification Product Code
FYD  
Date Received10/03/2005
Decision Date 02/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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