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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Theophylline Control Materials
510(k) Number K914251
Device Name MODEL IRC PASSPORT NEBULIZER
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 Number862.3280
Classification Product Code
LAW  
Date Received09/23/1991
Decision Date 01/24/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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