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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 K944534
Device Name PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS
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 11/29/1994
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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