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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 K830046
Device Name MODEL HI-FLO2 OXYGEN RICH AIR SUPPLY
Applicant
GREENE & KELLOGG, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GREENE & KELLOGG, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5440
Classification Product Code
CAW  
Date Received01/10/1983
Decision Date 02/07/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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