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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K841158
Device Name NEBULO 28 NEBULIZER KIT
Applicant
INSPIRON CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
INSPIRON CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5450
Classification Product Code
BTT  
Date Received03/19/1984
Decision Date 03/30/1984
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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