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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 K001704
Device Name ATHOS
Applicant
Cosmos Medical Technology
42230 Zevo Dr.
Temecula,  CA  92590
Applicant Contact JOHN CLARK
Correspondent
Cosmos Medical Technology
42230 Zevo Dr.
Temecula,  CA  92590
Correspondent Contact JOHN CLARK
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/05/2000
Decision Date 08/31/2000
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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