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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 K854833
Device Name MDS-83 IN DERMATOLOGICAL/PLASTIC SURGERY APPLICATI
Applicant
Meditec, Inc.
616 E. St.
Clearwater,  FL  33516
Applicant Contact EVA M PELC
Correspondent
Meditec, Inc.
616 E. St.
Clearwater,  FL  33516
Correspondent Contact EVA M PELC
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/29/1985
Decision Date 04/04/1986
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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