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510(k) K951697

PEDIATRIC ENDOTRACHEAL TUBE by Unomedical Sdn Bhd — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1995
Date Received
April 12, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

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