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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name attachment, breathing, positive end expiratory pressure
510(k) Number K133210
Device Name B&B BUBBLER
Applicant
S & T MEDICAL TECHNOLOGIES, INC.
1954 KELLOGG AVENUE
SUITE 100
CARLSBAD,  CA  92008
Applicant Contact DERICK CORRENTE
Correspondent
S & T MEDICAL TECHNOLOGIES, INC.
1954 KELLOGG AVENUE
SUITE 100
CARLSBAD,  CA  92008
Correspondent Contact DERICK CORRENTE
Regulation Number868.5965
Classification Product Code
BYE  
Date Received10/17/2013
Decision Date 03/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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