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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Circuit, Breathing (W Connector, Adaptor, Y Piece)
510(k) Number K944533
Device Name PRIMA, INC. ADULT ANESTHESIA CIRCUIT
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 Number868.5240
Classification Product Code
CAI  
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
Predetermined Change
Control Plan Authorized		 No
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