K853200Substantially Equivalent

5X2 Satalec Chiropody Case

Name: K853200 5X2 Satalec Chiropody Case
Creator: Spelna, Inc.
Published: 1985-10-18
License: https://open.fda.gov/license/

Spelna, Inc., Fredericksburg VA / Traditional, Substantially Equivalent

FDA source

K853200 is the FDA 510(k) clearance record for 5X2 SATALEC CHIROPODY CASE, cleared for Spelna, Inc. on 1985-10-18. FDA records list 11 510(k) clearances for Spelna, Inc., from 1982-06-25 to 1986-01-30. As of 2026-09-10, FDA records show no recalls naming K853200.

Clearance record

Decision date: 1985-10-18
Received: 1985-06-14 (126 days to decision)
Review panel: Unknown
Applicant: Spelna, Inc. P.O. Box 3395, Fredericksburg VA
Third party review: No