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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 K955549
Device Name OXLIFE OXYGEN CONCENTRATORS
Applicant
Oxlife, Inc.
1432 Viscaya Pkwy.
Cape Coral,  FL  33990
Applicant Contact STUART BASSINE
Correspondent
Oxlife, Inc.
1432 Viscaya Pkwy.
Cape Coral,  FL  33990
Correspondent Contact STUART BASSINE
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/05/1995
Decision Date 03/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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