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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 K931473
Device Name IMPACT MODEL 753
Applicant
IMPACT INSTRUMENTATION, INC.
P.O. BOX 508
WEST CALDWELL,  NJ  07006
Applicant Contact LESLIE SHERMAN
Correspondent
IMPACT INSTRUMENTATION, INC.
P.O. BOX 508
WEST CALDWELL,  NJ  07006
Correspondent Contact LESLIE SHERMAN
Regulation Number868.5925
Classification Product Code
BTL  
Date Received03/24/1993
Decision Date 12/30/1994
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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