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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 K882208
Device Name MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES
Applicant
Linde Div. Union Carbide Corp.
P.O. Box 6744,
200 Cottontail Ln.
Somerset,  NJ  08875
Applicant Contact SUZANNE G FIORINO
Correspondent
Linde Div. Union Carbide Corp.
P.O. Box 6744,
200 Cottontail Ln.
Somerset,  NJ  08875
Correspondent Contact SUZANNE G FIORINO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/26/1988
Decision Date 08/03/1988
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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