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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Exhaust, Surgical
510(k) Number K911154
Device Name SUN MEDICAL SMOKE/FLUID EVAC SYST, MODEL SFE-200
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 Number878.5070
Classification Product Code
FYD  
Date Received03/15/1991
Decision Date 07/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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