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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 K850628
Device Name SHARPLAN 1040 CO/2 SURGICAL LASER
Applicant
Laser Industries , Ltd.
Pennie & Edmonds
1155 Ave. Of The Americas
New York,  NY  10036
Applicant Contact FRANK E MORRIS
Correspondent
Laser Industries , Ltd.
Pennie & Edmonds
1155 Ave. Of The Americas
New York,  NY  10036
Correspondent Contact FRANK E MORRIS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/19/1985
Decision Date 08/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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