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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 K894997
Device Name PRESTO DIAGNOSTIC SPIROMETER
Applicant
TAMARAC SYSTEMS CORP.
4890 IRONTON ST., SUITE 6L
DENVER,  CO  80239
Applicant Contact CONNELLY-LYNN
Correspondent
TAMARAC SYSTEMS CORP.
4890 IRONTON ST., SUITE 6L
DENVER,  CO  80239
Correspondent Contact CONNELLY-LYNN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/08/1989
Decision Date 10/30/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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