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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 K881935
Device Name MICROCIRRUS MEDICAL NEBULIZER
Applicant
Dhd Medical Products Div. Diemolding Corp.
Division Of Diemolding Corp.
Canastota,  NY  13032
Applicant Contact RONALD N MCHENRY
Correspondent
Dhd Medical Products Div. Diemolding Corp.
Division Of Diemolding Corp.
Canastota,  NY  13032
Correspondent Contact RONALD N MCHENRY
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/09/1988
Decision Date 06/22/1988
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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