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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K883008
Device Name PULMONARY FORCED FLOW SYSTEM (PUFFS)
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 Number868.1890
Classification Product Code
BTY  
Date Received07/18/1988
Decision Date 09/29/1988
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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