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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 K910435
Device Name LIFE OXYGENPAC 6/12 LPM
Applicant
LIFE CORP.
P.O. BOX 300
W140 N5566 LILLY ROAD
MENOMONEE FALLS,  WI  53051
Applicant Contact JOHN KIRCHGEORG
Correspondent
LIFE CORP.
P.O. BOX 300
W140 N5566 LILLY ROAD
MENOMONEE FALLS,  WI  53051
Correspondent Contact JOHN KIRCHGEORG
Regulation Number868.5925
Classification Product Code
BTL  
Date Received01/31/1991
Decision Date 06/17/1991
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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