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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 K092362
Device Name SLEEPWEAVER NASAL CPAP MASK
Applicant
Circadiance, LLC
3554 N. Hills Rd.
Murrysville,  PA  15668
Applicant Contact DAVID GROLL
Correspondent
Circadiance, LLC
3554 N. Hills Rd.
Murrysville,  PA  15668
Correspondent Contact DAVID GROLL
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/04/2009
Decision Date 11/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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