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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 K031643
Device Name SPIROTEL, MODEL 29-1020
Applicant
Sdi Diagnostics, Inc.
10 Hampden Dr.
Easton,  MA  02375
Applicant Contact MICHAEL J BOYLE
Correspondent
Sdi Diagnostics, Inc.
10 Hampden Dr.
Easton,  MA  02375
Correspondent Contact MICHAEL J BOYLE
Regulation Number868.1840
Classification Product Code
BZG  
Date Received05/27/2003
Decision Date 12/09/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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