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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., Ste 1-224
San Diego,  CA  92129
Applicant Contact Warren G. Young
Correspondent
TereoPneuma
13223 Black Mountain Rd., Ste 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
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