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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 K942571
Device Name HYPER-INFLATION BAG
Applicant
MED-PLASTICS INTL., INC.
5668 WEST 73RD. ST.
INDIANAPOLIS,  IN  46278
Applicant Contact TERRY G ROSENKOETTER
Correspondent
MED-PLASTICS INTL., INC.
5668 WEST 73RD. ST.
INDIANAPOLIS,  IN  46278
Correspondent Contact TERRY G ROSENKOETTER
Regulation Number868.5905
Classification Product Code
NHK  
Date Received05/31/1994
Decision Date 06/10/1994
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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