Midas Rex Surgical Rubber Dam

FDA 510(k) K854462 · Midas Rex Pneumatic Tools, Inc.

Substantially Equivalent

510(k) numberK854462

Submission

Device name
Midas Rex Surgical Rubber Dam
Applicant
Midas Rex Pneumatic Tools, Inc.
Fort Worth, TX, US
Received
November 6, 1985
Decision date
November 22, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

More from Midas Rex Pneumatic Tools, Inc.

510(k)DeviceDecision
K972289Midas Rex MotorHBB · Traditional 09/12/1997SE
K970965Midas Rex III Motor and Attachments (Midas III)ERL · Traditional 04/09/1997SE
K962483Midas Rex III MotorHBB · Traditional 11/19/1996SE
K953434Midas Rex Motors, (Midas I, Midas II & Convertible Models)HBB · Traditional 05/16/1996SE
K954076Midas Rex Drill Attachments & Twist DrillsGET · Traditional 10/18/1995SE
K953433Midas Rex Telescoping SystemGET · Traditional 09/15/1995SE
K953432Rotating, Fixed Footed, Fixed Shield Attachments, Dissecting ToolsGET · Traditional 09/14/1995SE
K952463GS & GS20 Surgical Tool SystemGET · Traditional 07/17/1995SE
K952300Midas Rex Motors (Midas I, II & Convertible Models)GET · Traditional 05/26/1995SE
K900388Modified Sterilization of Drills, Burrs, TrephinesHBE · Traditional 05/07/1990SE

Questions and answers

When was Midas Rex Surgical Rubber Dam cleared by the FDA?

Midas Rex Surgical Rubber Dam (K854462) received a 510(k) decision of Substantially Equivalent on November 22, 1985, 16 days after the submission was received.