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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 K904162
Device Name CARBON DIOXIDE FLOWTHROUGH LASER MIXTURES
Applicant
Norco, Inc.
1121 W. Amity
Boise,  ID  83705
Applicant Contact LYLE FEELY
Correspondent
Norco, Inc.
1121 W. Amity
Boise,  ID  83705
Correspondent Contact LYLE FEELY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/11/1990
Decision Date 10/19/1990
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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