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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 K032397
Device Name DUAL YELLOW LASER, MODEL DUAL YELLOW D10B
Applicant
Norseld Pty., Ltd.
342 Sunset Bay Rd.
Hot Springs,  AR  71913
Applicant Contact ROGER W BARNES
Correspondent
Norseld Pty., Ltd.
342 Sunset Bay Rd.
Hot Springs,  AR  71913
Correspondent Contact ROGER W BARNES
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/04/2003
Decision Date 05/27/2004
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
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