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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 K120757
Device Name SLEEPWEAVER ELAN NASAL CPAP MASK
Applicant
CIRCADIANCE LLC
1060 corporate lane
export,  PA  15632
Contact david groll
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/13/2012
Decision Date 04/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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