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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 K904625
Device Name SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM
Applicant
Synectics-Dantec
Renstienas Gata 12, 5tr.
S-116 28 Stockholm
Sweden,  SE S-116 28
Applicant Contact ANNA PETTERSSON
Correspondent
Synectics-Dantec
Renstienas Gata 12, 5tr.
S-116 28 Stockholm
Sweden,  SE S-116 28
Correspondent Contact ANNA PETTERSSON
Regulation Number868.1840
Classification Product Code
BZG  
Date Received10/10/1990
Decision Date 08/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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