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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 K953784
Device Name UNICOR, INC. CORRUGATED TUBING
Applicant
UNICOR, INC.
151 GOLD STAR DR., S.W.
CLEVELAND,  TN  37323
Applicant Contact LORETTA J HART
Correspondent
UNICOR, INC.
151 GOLD STAR DR., S.W.
CLEVELAND,  TN  37323
Correspondent Contact LORETTA J HART
Regulation Number868.5975
Classification Product Code
BZO  
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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