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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 K020330
Device Name DEPLOYABLE OXYGEN CONCENTRATION SYSTEM (DOCS)
Applicant
PACIFIC CONSOLIDATED INDUSTRIES LLP
3430 WEST CARRIAGE DR.
SANTA ANA,  CA  92704
Applicant Contact LEE W SMITH
Correspondent
PACIFIC CONSOLIDATED INDUSTRIES LLP
3430 WEST CARRIAGE DR.
SANTA ANA,  CA  92704
Correspondent Contact LEE W SMITH
Regulation Number868.5440
Classification Product Code
CAW  
Date Received01/31/2002
Decision Date 04/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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