K834239Substantially Equivalent

Sdi C-Flex Sterile Light Handle

Name: K834239 Sdi C-Flex Sterile Light Handle
Creator: Sterile Design, Inc.
Published: 1984-04-25
License: https://open.fda.gov/license/

Sterile Design, Inc., Walker MI / Traditional, Substantially Equivalent

FDA source

K834239 is the FDA 510(k) clearance record for SDI C-FLEX STERILE LIGHT HANDLE, cleared for Sterile Design, Inc. on 1984-04-25. FDA records list 10 510(k) clearances for Sterile Design, Inc., from 1979-10-02 to 1994-03-16. As of 2026-09-10, FDA records show no recalls naming K834239.

Clearance record

Decision date: 1984-04-25
Received: 1983-12-06 (141 days to decision)
Review panel: Unknown
Applicant: Sterile Design, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review: No