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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 K972992
Device Name CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS
Applicant
Ceramatec, Inc.
2425 S. 900 W.
Salt Lake City,  UT  84119
Applicant Contact GORDON ROTH
Correspondent
Ceramatec, Inc.
2425 S. 900 W.
Salt Lake City,  UT  84119
Correspondent Contact GORDON ROTH
Regulation Number868.1720
Classification Product Code
CCL  
Date Received08/12/1997
Decision Date 03/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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