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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K080256
Device Name PULMODYNE CHF FLOW GENERATOR SYSTEM
Applicant
PULMODYNE
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  33134 -2958
Applicant Contact PAUL DRYDEN
Correspondent
PULMODYNE
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  33134 -2958
Correspondent Contact PAUL DRYDEN
Regulation Number868.5965
Classification Product Code
BYE  
Date Received01/31/2008
Decision Date 05/09/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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