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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 K905697
Device Name POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE
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 Number868.5925
Classification Product Code
BTL  
Date Received12/24/1990
Decision Date 12/27/1990
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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