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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 K061099
Device Name BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003
Applicant
HOFFMAN LABORATORIES, LLC
9305 ETON AVENUE
CHATSWORTH,  CA  91311
Applicant Contact KEITH BOSECKER
Correspondent
HOFFMAN LABORATORIES, LLC
9305 ETON AVENUE
CHATSWORTH,  CA  91311
Correspondent Contact KEITH BOSECKER
Regulation Number868.5905
Classification Product Code
BZD  
Date Received04/19/2006
Decision Date 08/11/2006
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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