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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 K870861
Device Name UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR
Applicant
Impact Instrumentation, Inc.
P.O. Box 508
West Caldwell,  NJ  07006
Applicant Contact LESLIE H SHERMAN
Correspondent
Impact Instrumentation, Inc.
P.O. Box 508
West Caldwell,  NJ  07006
Correspondent Contact LESLIE H SHERMAN
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/03/1987
Decision Date 01/19/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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