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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
510(k) Number K893827
Device Name PEAK FLOW RATE METER
Applicant
LAYTECH MEDICAL CO.
816 NICHOLS
ARLINGTON HEIGHTS,  IL  60004
Applicant Contact CATHERINE S LAYTON
Correspondent
LAYTECH MEDICAL CO.
816 NICHOLS
ARLINGTON HEIGHTS,  IL  60004
Correspondent Contact CATHERINE S LAYTON
Regulation Number876.1800
Classification Product Code
FFG  
Date Received05/24/1989
Decision Date 08/11/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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