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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K092224
FOIA Releasable 510(k) K092224
Device Name TIGR SURGICAL MESH , MODEL WK-6
Applicant
NOVUS SCIENTIFIC PTE LTD
NORDIC EUROPEAN CENTRE, 3
INTERNATIONAL BUSINESS PARK
#01-20, SINGAPORE,  SG 609927
Applicant Contact KELVIN KOH
Correspondent
NOVUS SCIENTIFIC PTE LTD
NORDIC EUROPEAN CENTRE, 3
INTERNATIONAL BUSINESS PARK
#01-20, SINGAPORE,  SG 609927
Correspondent Contact KELVIN KOH
Regulation Number878.3300
Classification Product Code
FTL  
Date Received07/23/2009
Decision Date 01/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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