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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K033962
Device Name LAD (EPITURE EASYTOUCH), MODEL LAD-08
Applicant
Norwood Abbey , Ltd.
63 Wells Rd.
Chelsea Hgts., Victoria,  AU 3196
Applicant Contact PAUL CLARK
Correspondent
Norwood Abbey , Ltd.
63 Wells Rd.
Chelsea Hgts., Victoria,  AU 3196
Correspondent Contact PAUL CLARK
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/22/2003
Decision Date 02/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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