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510(k) K073383

WELL LEAD REINFORCED ENDOTRACHEAL TUBE by Well Lead Medical Instruments — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 2008
Date Received
December 3, 2007
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

Other clearances by Well Lead Medical Instruments

  • K082815 — WELL LEAD SILICONE AND LATEX FOLEY CATHETERS (October 8, 2008)
  • K042683 — WELL LEAD ENDOTRACHEAL TUBE (February 18, 2005)
  • K042684 — WELL LEAD TRACHEOSTOMY TUBE (February 17, 2005)

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