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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 K821191
Device Name STER-O-MIST 1000 ML
Applicant
Inhalation Therapy Equipment, Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Inhalation Therapy Equipment, Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/27/1982
Decision Date 05/13/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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