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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 K942865
Device Name LASER GAS MIXTURE
Applicant
Nordan Smith Welding Supplies
5051 Hwy. 42
P.O. Box 107
Hattiesburg,  MS  39403
Applicant Contact WILLIAM DOWDEN
Correspondent
Nordan Smith Welding Supplies
5051 Hwy. 42
P.O. Box 107
Hattiesburg,  MS  39403
Correspondent Contact WILLIAM DOWDEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/17/1994
Decision Date 08/23/1994
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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