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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, pulmonary function data
510(k) Number K946077
Device Name DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS
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 Number868.1880
Classification Product Code
BZC  
Date Received12/13/1994
Decision Date 09/15/1995
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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