K860068Substantially Equivalent

Foot Pedal Cover

Name: K860068 Foot Pedal Cover
Creator: O.R. Concepts, Inc.
Published: 1986-01-27
License: https://open.fda.gov/license/

O.R. Concepts, Inc., Irving TX / Traditional, Substantially Equivalent

FDA source

K860068 is the FDA 510(k) clearance record for FOOT PEDAL COVER, cleared for O.R. Concepts, Inc. on 1986-01-27. FDA records list 34 510(k) clearances for O.R. Concepts, Inc., from 1986-01-27 to 1994-08-17. As of 2026-09-10, FDA records show no recalls naming K860068.

Clearance record

Decision date: 1986-01-27
Received: 1986-01-06 (21 days to decision)
Review panel: Unknown
Applicant: O.R. Concepts, Inc. 1328 Shady Springs Ct., Irving TX
Third party review: No