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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name connector, airway (extension)
510(k) Number K944532
Device Name PRIMA, INC. VENTILATOR HOSES
Applicant
PRIMA, INC.
1300 25TH ST. PLAZA
SUITE 11
CLEVELAND,  TN  37311
Applicant Contact LORETTA J HART
Correspondent
PRIMA, INC.
1300 25TH ST. PLAZA
SUITE 11
CLEVELAND,  TN  37311
Correspondent Contact LORETTA J HART
Regulation Number868.5810
Classification Product Code
BZA  
Date Received09/15/1994
Decision Date 12/02/1994
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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