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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Pump, Nebulizer, Manual
510(k) Number K802430
Device Name NEBULIZER, MEDICINAL
Applicant
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DHD MEDICAL PRODUCTS DIV. DIEMOLDING CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number874.5220
Classification Product Code
EPN  
Date Received10/06/1980
Decision Date 10/23/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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