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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K051476
Device Name UNI-VENT MODEL 73X
Applicant
Impact Instrumentation, Inc.
27 Fairfield Pl.
P.O. Box 508
West Caldwell,  NJ  07006 -0508
Applicant Contact LESLIE H SHERMAN
Correspondent
Impact Instrumentation, Inc.
27 Fairfield Pl.
P.O. Box 508
West Caldwell,  NJ  07006 -0508
Correspondent Contact LESLIE H SHERMAN
Regulation Number868.5925
Classification Product Code
BTL  
Date Received06/03/2005
Decision Date 10/28/2005
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
Recalls CDRH Recalls
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