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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 K210844
Device Name DreamWear Silicone Pillows Mask
Applicant
Respironics, Inc.
1740 Golden Mile Highway
Monroeville,  PA  15146
Applicant Contact Steve Lawrie
Correspondent
Respironics, Inc.
1740 Golden Mile Highway
Monroeville,  PA  15146
Correspondent Contact Steve Lawrie
Regulation Number868.5905
Classification Product Code
BZD  
Date Received03/22/2021
Decision Date 08/24/2021
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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