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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 K162905
Device Name SleepWeaver 3D Nasal Mask
Applicant
Circadiance, LLC
1300 Rodi Rd.
Turtle Creek,  PA  15145
Applicant Contact JAMES GIANOUTSOS
Correspondent
Circadiance, LLC
1300 Rodi Rd.
Turtle Creek,  PA  15145
Correspondent Contact JAMES GIANOUTSOS
Regulation Number868.5905
Classification Product Code
BZD  
Date Received10/17/2016
Decision Date 03/15/2017
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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