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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 K874948
Device Name SUN MEDICAL SMOKE EVACUATOR SYSTEM
Applicant
Sun Medical, Inc.
1170 Corporate Dr. W.
Suite 100
Arlington,  TX  76006
Applicant Contact HOWARD PENNEY
Correspondent
Sun Medical, Inc.
1170 Corporate Dr. W.
Suite 100
Arlington,  TX  76006
Correspondent Contact HOWARD PENNEY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/02/1987
Decision Date 02/18/1988
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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