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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 K091238
Device Name UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+
Applicant
Impact Instrumentation, Inc.
27 Fairfield Pl.
West Caldwell,  NJ  07006 -0508
Applicant Contact LESLIE H SHERMAN
Correspondent
Impact Instrumentation, Inc.
27 Fairfield Pl.
West Caldwell,  NJ  07006 -0508
Correspondent Contact LESLIE H SHERMAN
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
DQA  
Date Received04/27/2009
Decision Date 08/13/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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