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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 K062913
Device Name ASTRAGUARD PULMONARY FUNCTION FILTER
Applicant
SDI DIAGNOSTICS, INC.
10 HAMPDEN DR.
EASTON,  MA  02375
Applicant Contact COSIMO CARIOLO
Correspondent
SDI DIAGNOSTICS, INC.
10 HAMPDEN DR.
EASTON,  MA  02375
Correspondent Contact COSIMO CARIOLO
Regulation Number868.1840
Classification Product Code
BZG  
Date Received09/27/2006
Decision Date 01/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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