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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, Helium, Gaseous-Phase
510(k) Number K903939
Device Name PANDA HELIUM GAS ANALYZER
Applicant
Medical Associated Services, Inc.
P.O. Box 530
Hatfield,  PA  19440
Applicant Contact MARK S ALSBERGE
Correspondent
Medical Associated Services, Inc.
P.O. Box 530
Hatfield,  PA  19440
Correspondent Contact MARK S ALSBERGE
Regulation Number868.1640
Classification Product Code
BSE  
Date Received08/27/1990
Decision Date 01/03/1991
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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