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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name resuscitator, manual, non self-inflating
510(k) Number K940255
Device Name HYPERINFLATION BAG SYSTEM
Applicant
NUTEC, INC.
1 S 241 NORTH FLANDERS LN.
WINFIELD,  IL  60190
Applicant Contact CHARLES F COSENTINO
Correspondent
NUTEC, INC.
1 S 241 NORTH FLANDERS LN.
WINFIELD,  IL  60190
Correspondent Contact CHARLES F COSENTINO
Regulation Number868.5905
Classification Product Code
NHK  
Date Received01/19/1994
Decision Date 02/17/1994
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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