K780282Substantially Equivalent

Barrier Hip Pack W/ Fabric 450

Name: K780282 Barrier Hip Pack W/ Fabric 450
Creator: Surgikos, Inc.
Published: 1978-02-28
License: https://open.fda.gov/license/

Surgikos, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K780282 is the FDA 510(k) clearance record for BARRIER HIP PACK W/ FABRIC 450, cleared for Surgikos, Inc. on 1978-02-28. FDA records list 56 510(k) clearances for Surgikos, Inc., from 1976-08-06 to 1988-03-21. As of 2026-09-10, FDA records show one recall naming K780282.

Clearance record

Decision date: 1978-02-28
Received: 1978-02-21 (7 days to decision)
Review panel: Unknown
Applicant: Surgikos, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No