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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K911450
Device Name INFANT VENTILATOR
Applicant
PREEMICARE CORP.
3300 WALNUT BEND LN.
HOUSTON,  TX  77042
Applicant Contact HARVEY KNAUSS
Correspondent
PREEMICARE CORP.
3300 WALNUT BEND LN.
HOUSTON,  TX  77042
Correspondent Contact HARVEY KNAUSS
Regulation Number868.5895
Classification Product Code
CBK  
Date Received03/25/1991
Decision Date 06/18/1991
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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