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510(k) K854462

MIDAS REX SURGICAL RUBBER DAM by Midas Rex Pneumatic Tools, Inc.

K854462 is an FDA 510(k) premarket notification submitted by Midas Rex Pneumatic Tools, Inc. for the device "MIDAS REX SURGICAL RUBBER DAM". The FDA issued a decision of Substantially Equivalent on November 22, 1985. Midas Rex Pneumatic Tools, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1985
Date Received
November 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Midas Rex Pneumatic Tools, Inc.

  • K972289 — MIDAS REX MOTOR (September 12, 1997)
  • K970965 — MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III) (April 9, 1997)
  • K962483 — MIDAS REX III MOTOR (November 19, 1996)
  • K953434 — MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS) (May 16, 1996)
  • K954076 — MIDAS REX DRILL ATTACHMENTS & TWIST DRILLS (October 18, 1995)
  • K953433 — MIDAS REX TELESCOPING SYSTEM (September 15, 1995)
  • K953432 — ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS (September 14, 1995)
  • K952463 — GS & GS20 SURGICAL TOOL SYSTEM (July 17, 1995)
  • K952300 — MIDAS REX MOTORS (MIDAS I, II & CONVERTIBLE MODELS) (May 26, 1995)
  • K900388 — MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES (May 7, 1990)

FDA data resources