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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
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