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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 K872578
Device Name MDS-90 ARGON DYE LASER FOR DERMATOLOGY
Applicant
Meditec of America
C/O Mackeen Consultants Ltd.
4903 Sangamore Rd.
Bethesda,  MD  20816
Applicant Contact DONALD L MACKEEN
Correspondent
Meditec of America
C/O Mackeen Consultants Ltd.
4903 Sangamore Rd.
Bethesda,  MD  20816
Correspondent Contact DONALD L MACKEEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/30/1987
Decision Date 10/01/1987
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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