K854248Substantially Equivalent

Goodley Polyaxial Cervical Traction Unit

Name: K854248 Goodley Polyaxial Cervical Traction Unit
Creator: E-Z-Em, Inc.
Published: 1985-11-15
License: https://open.fda.gov/license/

E-Z-EM, Inc, Westbury NY / Traditional, Substantially Equivalent

FDA source

K854248 is the FDA 510(k) clearance record for GOODLEY POLYAXIAL CERVICAL TRACTION UNIT, cleared for E-Z-Em, Inc. on 1985-11-15. FDA records list 56 510(k) clearances for E-Z-Em, Inc., from 1977-09-12 to 2007-06-13. As of 2026-09-10, FDA records show no recalls naming K854248.

Clearance record

Decision date: 1985-11-15
Received: 1985-10-21 (25 days to decision)
Review panel: Unknown
Applicant: E-Z-Em, Inc. 717 Main St., Westbury NY
Third party review: No