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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 K854550
Device Name MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA
Applicant
MEDIPART JERRY ALEXANDER
607 SPRING BEACH RD.
CARY,  IL  60013
Applicant Contact JERRY ALEXANDER
Correspondent
MEDIPART JERRY ALEXANDER
607 SPRING BEACH RD.
CARY,  IL  60013
Correspondent Contact JERRY ALEXANDER
Regulation Number868.5640
Classification Product Code
CCQ  
Date Received11/13/1985
Decision Date 12/19/1985
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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