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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 K943479
Device Name GENEMED YAG 1000 MEDICAL LASER
Applicant
Genemed, Inc.
P.O. Box 16
Middlebury,  CT  06762
Applicant Contact DAVID R BALZER
Correspondent
Genemed, Inc.
P.O. Box 16
Middlebury,  CT  06762
Correspondent Contact DAVID R BALZER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/19/1994
Decision Date 09/29/1994
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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