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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 K882516
Device Name THREE-COMPONENT MEDICAL LASER GAS MIXTURES
Applicant
Matheson Gas Products, Inc.
932 Paterson Plank Rd.
East Rutheford,  NJ  07073
Applicant Contact DENNIS R DEPOL
Correspondent
Matheson Gas Products, Inc.
932 Paterson Plank Rd.
East Rutheford,  NJ  07073
Correspondent Contact DENNIS R DEPOL
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/20/1988
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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