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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, facility use
510(k) Number K030515
Device Name HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS
Applicant
HANS RUDOLPH, INC.
7200 WYANDOTTE
KANSAS CITY,  MO  64114
Applicant Contact KEVIN RUDOLPH
Correspondent
HANS RUDOLPH, INC.
7200 WYANDOTTE
KANSAS CITY,  MO  64114
Correspondent Contact KEVIN RUDOLPH
Regulation Number868.5895
Classification Product Code
CBK  
Date Received02/19/2003
Decision Date 05/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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