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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 K102750
Device Name O2-IN-A-BOX, O2-IN-A-BOX
Applicant
GETO2, INC.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
GETO2, INC.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received09/23/2010
Decision Date 02/11/2011
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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