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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 K896412
Device Name GAS MIXTURES AS DEVICE COMPONENTS
Applicant
Spectra Gases, Inc.
320 Mount Pleasant Ave.
Newark,  NJ  07104
Applicant Contact JAMES E GERETY
Correspondent
Spectra Gases, Inc.
320 Mount Pleasant Ave.
Newark,  NJ  07104
Correspondent Contact JAMES E GERETY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/08/1989
Decision Date 02/01/1990
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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