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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 K100957
Device Name DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS), MODEL 66, DEPLOYABLE OXYGEN CEONCENTRATION
Applicant
PACIFIC CONSOLIDATED INDUSTRIES, LLC
12201 MAGNOLIA AVE.
RIVERSIDE,  CA  92503
Applicant Contact GARY CLARK
Correspondent
PACIFIC CONSOLIDATED INDUSTRIES, LLC
12201 MAGNOLIA AVE.
RIVERSIDE,  CA  92503
Correspondent Contact GARY CLARK
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/07/2010
Decision Date 01/21/2011
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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