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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 Interpretor (Diagnostic)
510(k) Number K864911
Device Name EXERSYSTEM(TM) MMC 5000
Applicant
MED SCIENCE
1455 PAGE INDUSTRIAL BLVD.
ST. LOUIS,  MO  63132
Applicant Contact NORMAN E ROWE
Correspondent
MED SCIENCE
1455 PAGE INDUSTRIAL BLVD.
ST. LOUIS,  MO  63132
Correspondent Contact NORMAN E ROWE
Regulation Number868.1900
Classification Product Code
BZM  
Date Received12/15/1986
Decision Date 08/21/1987
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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