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510(k) K050803

PEDIATRIC CUFFED AND UNCUFFED ET TUBES; STANDARD CUFFED AND UNCUFFED ET TUBES by Vitaid, Ltd. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2005
Date Received
March 30, 2005
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 Vitaid, Ltd.

  • K932647 — WIRE REINFORCED ENDOTRACHEAL TUBE (November 2, 1993)
  • K901738 — SELFCATH (June 27, 1990)
  • K894883 — PHYCON ALL SILICONE BALLOON CATHETER (April 25, 1990)
  • K894794 — AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP (November 21, 1989)
  • K894669 — LASER SHIELDING TUBE (October 13, 1989)
  • K894337 — UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM (September 29, 1989)

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