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510(k) K941384

TRAKEEZ by Ergomed, Inc. — Product Code CBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1994
Date Received
March 22, 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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  • K942016 — TRACH TIE, VENTILATOR TUBING HOLDER (May 24, 1994)
  • K940448 — NETOH ENDOTRACHEAL TUBE HOLDER (February 22, 1994)