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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 K081267
Device Name HYGEIA-5 OXYGEN CONCENTRATOR
Applicant
KEDL INTERNATION LIMITED
7690 CAMERON CIRCLE
FORT MYERS,  FL  33912
Applicant Contact Lee Leichter
Correspondent
KEDL INTERNATION LIMITED
7690 CAMERON CIRCLE
FORT MYERS,  FL  33912
Correspondent Contact Lee Leichter
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/05/2008
Decision Date 09/23/2008
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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