K854462Substantially Equivalent

Midas Rex Surgical Rubber Dam

Name: K854462 Midas Rex Surgical Rubber Dam
Creator: Midas Rex Pneumatic Tools, Inc.
Published: 1985-11-22
License: https://open.fda.gov/license/

Midas Rex Pneumatic Tools, Inc., Fort Worth TX / Traditional, Substantially Equivalent

FDA source

K854462 is the FDA 510(k) clearance record for MIDAS REX SURGICAL RUBBER DAM, cleared for Midas Rex Pneumatic Tools, Inc. on 1985-11-22. FDA records list 12 510(k) clearances for Midas Rex Pneumatic Tools, Inc., from 1985-11-13 to 1997-09-12. As of 2026-09-10, FDA records show no recalls naming K854462.

Clearance record

Decision date: 1985-11-22
Received: 1985-11-06 (16 days to decision)
Review panel: Unknown
Applicant: Midas Rex Pneumatic Tools, Inc. 3001 Race St., Fort Worth TX
Third party review: No