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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheters, suction, tracheobronchial
510(k) Number K862132
Device Name HCI MECONIUM ASPIRATOR
Applicant
HOSPITAL CONCEPTS, INC.
2701 W. ALAMEDA AVE., SUITE
406
BURBANK,  CA  91505
Applicant Contact PRADIP CHOKSI
Correspondent
HOSPITAL CONCEPTS, INC.
2701 W. ALAMEDA AVE., SUITE
406
BURBANK,  CA  91505
Correspondent Contact PRADIP CHOKSI
Regulation Number868.6810
Classification Product Code
BSY  
Date Received06/04/1986
Decision Date 06/19/1986
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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