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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tube, tracheal (w/wo connector)
510(k) Number K954754
Device Name WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
Applicant
UNOMEDICAL SDN BHD
P.O. BOX NO. 18
SUNGEI PATANI KEDAH
WEST MALAYSIA,  MY
Applicant Contact PATRICK J LAMB
Correspondent
UNOMEDICAL SDN BHD
P.O. BOX NO. 18
SUNGEI PATANI KEDAH
WEST MALAYSIA,  MY
Correspondent Contact PATRICK J LAMB
Regulation Number868.5730
Classification Product Code
BTR  
Date Received10/16/1995
Decision Date 12/08/1995
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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