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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name generator, oxygen, portable
510(k) Number K120566
Device Name O2PAK OXYGEN GENERATOR
Original Applicant
PACIFIC PRECISION PRODUCTS
9671 irvine center drive
irvine,  CA  92618
Original Contact gerald white
Regulation Number868.5440
Classification Product Code
CAW  
Date Received02/27/2012
Decision Date 07/24/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review Yes
Combination Product No
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