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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name meter, peak flow, spirometry
510(k) Number K770580
Device Name PEAK FLOW METER
Applicant
PROJECTS IN HEALTH
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PROJECTS IN HEALTH
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1860
Classification Product Code
BZH  
Date Received03/28/1977
Decision Date 08/04/1977
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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