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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 K151683
Device Name SleepWeaver Advance Pediatric Nasal CPAP Mask
Applicant
Circadiance, LLC
1060 Corporate Lane
Export,  PA  15632
Applicant Contact David Groll
Correspondent
Regulatory & Quality Solutions, LLC
2790 Mosside Blvd, Suite 800
Monroeville,  PA  15146
Correspondent Contact Pooja Roychoudhury
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/22/2015
Decision Date 04/05/2016
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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