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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 K894138
Device Name MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD
Applicant
MEDIPART JERRY ALEXANDER
607 SPRING BEACH RD.
CARY,  IL  60013
Applicant Contact JERY ALEXANDER
Correspondent
MEDIPART JERRY ALEXANDER
607 SPRING BEACH RD.
CARY,  IL  60013
Correspondent Contact JERY ALEXANDER
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/13/1989
Decision Date 09/26/1989
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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