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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 K951697
Device Name PEDIATRIC ENDOTRACHEAL TUBE
Applicant
Unomedical Sdn Bhd
P.O. Box # 18
Sungei Patani Kedah
West Malaysia,  MY
Applicant Contact PATRICK J LAMB
Correspondent
Unomedical Sdn Bhd
P.O. Box # 18
Sungei Patani Kedah
West Malaysia,  MY
Correspondent Contact PATRICK J LAMB
Regulation Number868.5730
Classification Product Code
BTR  
Date Received04/12/1995
Decision Date 05/22/1995
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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