K854068Substantially Equivalent

External Mechanical Fastener

Name: K854068 External Mechanical Fastener
Creator: Wells Johnson Co.
Published: 1985-11-22
License: https://open.fda.gov/license/

Wells Johnson Co., Tucson AZ / Traditional, Substantially Equivalent

FDA source

K854068 is the FDA 510(k) clearance record for EXTERNAL MECHANICAL FASTENER, cleared for Wells Johnson Co. on 1985-11-22. FDA records list 15 510(k) clearances for Wells Johnson Co., from 1983-10-19 to 1999-08-30. As of 2026-09-10, FDA records show no recalls naming K854068.

Clearance record

Decision date: 1985-11-22
Received: 1985-10-04 (49 days to decision)
Review panel: Unknown
Applicant: Wells Johnson Co. 2045 # Forbes Blvd., Suite 106, Tucson AZ
Third party review: No