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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K992643
Device Name MODEL IRC 1001 AEROSOL COMPRESSOR
Applicant
Invacare Corp.
One Invacare Way
P.O. Box 4028
Elyria,  OH  44036
Applicant Contact EDWARD A KROLL
Correspondent
Invacare Corp.
One Invacare Way
P.O. Box 4028
Elyria,  OH  44036
Correspondent Contact EDWARD A KROLL
Regulation Number868.5630
Classification Product Code
CAF  
Date Received08/06/1999
Decision Date 10/27/1999
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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