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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 K864087
Device Name PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM
Applicant
Medical Associated Services, Inc.
P.O. Box 530
Hatfield,  PA  19440
Applicant Contact MYERS, JR.
Correspondent
Medical Associated Services, Inc.
P.O. Box 530
Hatfield,  PA  19440
Correspondent Contact MYERS, JR.
Regulation Number868.1890
Classification Product Code
BTY  
Date Received10/21/1986
Decision Date 11/07/1986
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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