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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 K983020
Device Name COMPACT KTP LASER
Applicant
Cosmos Medical Technology
P.O. Box 27210
San Diego,  CA  92198
Applicant Contact JOHN P CLARK
Correspondent
Cosmos Medical Technology
P.O. Box 27210
San Diego,  CA  92198
Correspondent Contact JOHN P CLARK
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/31/1998
Decision Date 11/25/1998
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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