K842356Substantially Equivalent

Custom Sterile Procedure Kits

Name: K842356 Custom Sterile Procedure Kits
Creator: Sterile Design, Inc.
Published: 1985-03-21
License: https://open.fda.gov/license/

Sterile Design, Inc., Oldsmar FL / Traditional, Substantially Equivalent

FDA source

K842356 is the FDA 510(k) clearance record for CUSTOM STERILE PROCEDURE KITS, cleared for Sterile Design, Inc. on 1985-03-21. 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 K842356.

Clearance record

Decision date: 1985-03-21
Received: 1984-06-15 (279 days to decision)
Review panel: Unknown
Applicant: Sterile Design, Inc. P.O. Box 12100, Oldsmar FL
Third party review: No