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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 K090710
Device Name MERCURY CPAP
Applicant
MERCURY MEDICAL
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
MERCURY MEDICAL
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.5965
Classification Product Code
BYE  
Date Received03/18/2009
Decision Date 08/20/2009
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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