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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K040069
Device Name DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR
Applicant
Dymedix, Inc.
800 Levanger Ln.
Stoughton,  WI  53589
Applicant Contact Gary Syring
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462 -1298
Correspondent Contact ROBERT MOSENKIS
Regulation Number868.2375
Classification Product Code
MNR  
Date Received01/14/2004
Decision Date 05/05/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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