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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
510(k) Number K800763
Device Name MISER INHALATION DEVICE, PART NO. 700
Applicant
Vix Breathing Equipment Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Vix Breathing Equipment Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received04/07/1980
Decision Date 04/24/1980
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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