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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K893845
Device Name PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM
Applicant
MEDICAL ASSOCIATED SERVICES, INC.
P.O. BOX 530
HATFIELD,  PA  19440
Applicant Contact BOX 530
Correspondent
MEDICAL ASSOCIATED SERVICES, INC.
P.O. BOX 530
HATFIELD,  PA  19440
Correspondent Contact BOX 530
Regulation Number868.1880
Classification Product Code
BZC  
Date Received05/25/1989
Decision Date 10/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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