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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, diagnostic
510(k) Number K022276
Device Name KOKOMATE
Applicant
FERRARIS RESPIRATORY, INC.
908 MAIN ST.
LOUISVILLE,  CO  80027
Applicant Contact JIM LEWIS
Correspondent
FERRARIS RESPIRATORY, INC.
908 MAIN ST.
LOUISVILLE,  CO  80027
Correspondent Contact JIM LEWIS
Regulation Number868.1840
Classification Product Code
BZG  
Date Received07/15/2002
Decision Date 10/04/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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