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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device Indicating An Exhalation Event
510(k) Number K161953
Device Name ReDe Mask
Applicant
Tereopneuma
13223 Black Mountain Rd., Suite 1-224
San Diego,  CA  92129
Applicant Contact Warren G. Young
Correspondent
Tereopneuma
13223 Black Mountain Rd., Suite 1-224
San Diego,  CA  92129
Correspondent Contact Warren G. Young
Regulation Number868.2375
Classification Product Code
PRK  
Date Received07/18/2016
Decision Date 02/17/2017
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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