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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 K963229
Device Name SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS
Applicant
Sharplan Lasers, Inc.
33 Plan Way
Warwick,  RI  02886
Applicant Contact GEORGE J HATTUB
Correspondent
Sharplan Lasers, Inc.
33 Plan Way
Warwick,  RI  02886
Correspondent Contact GEORGE J HATTUB
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/19/1996
Decision Date 11/05/1996
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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