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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 K021685
Device Name VENTURE HOMEFILL II WITH OXYGEN CONSERVER
Applicant
Invacare Corp.
One Invacare Way
Elyria,  OH  44036 -2125
Applicant Contact EDWARD A KROLL
Correspondent
Invacare Corp.
One Invacare Way
Elyria,  OH  44036 -2125
Correspondent Contact EDWARD A KROLL
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/22/2002
Decision Date 07/23/2002
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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