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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 K882942
Device Name LASER MIXTURE
Applicant
Swisco, Inc.
P.O. Box 1563
Lake Charles,  LA  70602
Applicant Contact LEE PHILLIPS
Correspondent
Swisco, Inc.
P.O. Box 1563
Lake Charles,  LA  70602
Correspondent Contact LEE PHILLIPS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/07/1988
Decision Date 08/23/1988
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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