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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, non-continuous (respirator)
510(k) Number K071773
Device Name CPAP NASAL MASK WITH PILLOWS
Applicant
LIFESOURCE
3460 POINTE CREEK COURT #102
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
LIFESOURCE
3460 POINTE CREEK COURT #102
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/29/2007
Decision Date 09/12/2007
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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