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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 K952301
Device Name LASER GAS MIXTURE
Applicant
Airgas Management, Inc.
1515 Abby Aldrich
Kathy,  TX  77449
Applicant Contact RALPH A DIAZ
Correspondent
Airgas Management, Inc.
1515 Abby Aldrich
Kathy,  TX  77449
Correspondent Contact RALPH A DIAZ
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/16/1995
Decision Date 06/01/1995
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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