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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 K971964
Device Name OXLIFE EXCELL OXYGEN CONCENTRATORS
Applicant
OXLIFE, INC.
917 15TH AVENUE S.E.
CAPE CORAL,  FL  33990
Applicant Contact STUART BASSINE
Correspondent
OXLIFE, INC.
917 15TH AVENUE S.E.
CAPE CORAL,  FL  33990
Correspondent Contact STUART BASSINE
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/28/1997
Decision Date 08/15/1997
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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