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510(k) K942395

ENDOTRACHEAL TUBE HOLDER by S.T.I. Medical Products Corp. — Product Code CBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1994
Date Received
May 19, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Tracheal Tube
Device Class
Class I
Regulation Number
868.5770
Review Panel
AN
Submission Type

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  • K950930 — TRACHE-TITE (March 22, 1995)
  • K950318 — FLEX BLUE (February 13, 1995)
  • K934288 — HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR (June 9, 1994)
  • K942016 — TRACH TIE, VENTILATOR TUBING HOLDER (May 24, 1994)
  • K941384 — TRAKEEZ (April 19, 1994)
  • K940448 — NETOH ENDOTRACHEAL TUBE HOLDER (February 22, 1994)