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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 K033518
Device Name LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103
Applicant
CUSTOM PLASTIC PRODUCTS
28481 LA FALDA
LAGUNA NIGUEL,  CA  92677
Applicant Contact JIM BARLEY
Correspondent
CUSTOM PLASTIC PRODUCTS
28481 LA FALDA
LAGUNA NIGUEL,  CA  92677
Correspondent Contact JIM BARLEY
Regulation Number868.1840
Classification Product Code
BZG  
Date Received11/07/2003
Decision Date 03/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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