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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Oxygen, Topical, Extremity
510(k) Number K090681
Device Name TANSCU O2
Applicant
Electrochemical Oxygen Concepts, Inc.
10 E Scranton Ave., Suite 201
Lake Bluff,  IL  60044
Applicant Contact CARL JENKINS
Correspondent
Electrochemical Oxygen Concepts, Inc.
10 E Scranton Ave., Suite 201
Lake Bluff,  IL  60044
Correspondent Contact CARL JENKINS
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received03/16/2009
Decision Date 08/12/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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