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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 K953788
Device Name UNICOR, INC. GAS SAMPLING LINES & CONNECTORS
Applicant
UNICOR, INC.
1300 25TH ST.
SUITE 11
CLEVELAND,  TN  37311
Applicant Contact LORETTA J HART
Correspondent
UNICOR, INC.
1300 25TH ST.
SUITE 11
CLEVELAND,  TN  37311
Correspondent Contact LORETTA J HART
Regulation Number868.5240
Classification Product Code
CAI  
Date Received08/14/1995
Decision Date 09/19/1995
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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