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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 K092263
Device Name ENDURAVENT-5 VENTILATOR
Applicant
PROVIDENCE GLOBAL MEDICAL, INC.
4659 SOUTH, 2300 EAST #203
SALT LAKE CITY,  UT  84117
Applicant Contact HELEN REDD
Correspondent
PROVIDENCE GLOBAL MEDICAL, INC.
4659 SOUTH, 2300 EAST #203
SALT LAKE CITY,  UT  84117
Correspondent Contact HELEN REDD
Regulation Number868.5895
Classification Product Code
CBK  
Date Received07/28/2009
Decision Date 01/21/2010
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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