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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 K984081
Device Name EMOX
Applicant
EMOX 911 CC
P.O. BOX 79
SOMERSET WEST,  ZA 7129
Applicant Contact IVOR DUNCAN
Correspondent
EMOX 911 CC
P.O. BOX 79
SOMERSET WEST,  ZA 7129
Correspondent Contact IVOR DUNCAN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received11/16/1998
Decision Date 03/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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