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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name conserver, oxygen
510(k) Number K953852
Device Name MODEL IPD OXYGEN CONSERVING DEVICE
Applicant
INVACARE CORP.
899 CLEVELAND ST.
P.O. BOX 4028
ELYRIA,  OH  44036
Applicant Contact EDWARD A KROLL
Correspondent
INVACARE CORP.
899 CLEVELAND ST.
P.O. BOX 4028
ELYRIA,  OH  44036
Correspondent Contact EDWARD A KROLL
Regulation Number868.5905
Classification Product Code
NFB  
Date Received08/16/1995
Decision Date 11/22/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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