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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 K960820
Device Name SHARPLAN LASERS, INC. SILKTOUCH XJ SCANNER
Applicant
Sharplan Lasers, Inc.
One Pearl Ct.
Allendale,  NJ  07401
Applicant Contact GEORGE J HATTUB
Correspondent
Sharplan Lasers, Inc.
One Pearl Ct.
Allendale,  NJ  07401
Correspondent Contact GEORGE J HATTUB
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/29/1996
Decision Date 05/10/1996
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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