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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 K083751
Device Name INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100
Applicant
Invacare Corporation
One Invacare Way
P.O. Box 4028
Elyria,  OH  44036
Applicant Contact CARROLL MARTIN
Correspondent
Invacare Corporation
One Invacare Way
P.O. Box 4028
Elyria,  OH  44036
Correspondent Contact CARROLL MARTIN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/17/2008
Decision Date 05/21/2009
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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