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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, Carbon-Dioxide, Gaseous-Phase
510(k) Number K915228
Device Name DISPOSABLE CO2 GAS SAMPLING/OXYGEN DELIVERY CANNUL
Applicant
Hospitak, Inc.
1144 Rte. 109
Lindenhurst,  NY  11757
Applicant Contact WILLIAM J LACEY
Correspondent
Hospitak, Inc.
1144 Rte. 109
Lindenhurst,  NY  11757
Correspondent Contact WILLIAM J LACEY
Regulation Number868.1400
Classification Product Code
CCK  
Date Received11/20/1991
Decision Date 02/11/1992
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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