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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 K991569
Device Name HOME/COMMERCIAL OXYGEN UNIT BY SYSTEM O2
Applicant
02 MARKETING GROUP, INC.
11285 ELKINS RD.
SUITE H5
ROSWELL,  GA  30076
Applicant Contact LESTER FORD
Correspondent
02 MARKETING GROUP, INC.
11285 ELKINS RD.
SUITE H5
ROSWELL,  GA  30076
Correspondent Contact LESTER FORD
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/05/1999
Decision Date 08/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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