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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K953785
Device Name UNICOR, INC. VENTILATOR HOSES
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 Number868.5975
Classification Product Code
BZO  
Date Received08/14/1995
Decision Date 09/18/1995
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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