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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 K071928
Device Name THE INVACARE FLYER, MODEL IPC 100
Applicant
Invacare Corp.
One Invacare Way
P.O. Box 4028
Elyria,  OH  44036 -2125
Applicant Contact CARROLL MARTIN
Correspondent
Invacare Corp.
One Invacare Way
P.O. Box 4028
Elyria,  OH  44036 -2125
Correspondent Contact CARROLL MARTIN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received07/12/2007
Decision Date 12/12/2007
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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