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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Oxygen, Gaseous-Phase
510(k) Number K894918
Device Name HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.
Applicant
Mennen Medical, Inc.
10123 Main St.
Clarence,  NY  14031
Applicant Contact RICHARD WHITEHEAD
Correspondent
Mennen Medical, Inc.
10123 Main St.
Clarence,  NY  14031
Correspondent Contact RICHARD WHITEHEAD
Regulation Number868.1720
Classification Product Code
CCL  
Date Received08/02/1989
Decision Date 10/31/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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