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510(k) K930114

TRACHEOSTOMY T-TUBE by Invotec International, Inc. — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1993
Date Received
January 11, 1993
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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  • K911040 — INVOTEC MICROSCOPE DRAPE (June 3, 1991)
  • K911039 — INVOTEC EAR DRAPE (May 13, 1991)
  • K901923 — INVOTEC POLY-MESH MANDIBULAR TRAY (October 31, 1990)

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