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510(k) K894337

UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM by Vitaid, Ltd. — Product Code CBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1989
Date Received
July 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5740
Review Panel
AN
Submission Type

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  • 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)

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