STERILEDGE SELF SEAL POUCH— 510(k) K810469

Name: FDA 510(k) clearance K810469
Creator: U.S. Food and Drug Administration
Published: 1981-06-01

Substantially Equivalent

Beacon Converters, Inc.

FDA 510(k) clearance K810469 for STERILEDGE SELF SEAL POUCH, Substantially Equivalent on 1981-06-01. Applicant: Beacon Converters, Inc.. Device class: 2.

Clearance details

Applicant: Beacon Converters, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 1981-02-23
Decision date: 1981-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCT

view all

K253988 — LiteSet Trays2026-09-08
K261935 — Surgical and Prosthetic Trays2026-09-04
K253187 — SteriBest® Sterilization Tray System2026-06-18
K252854 — SteriTite Container System with MediTray Products2026-06-03
K260726 — Straumann® ProClean Cassette (041.800; 041.801)2026-06-03

More clearances from Beacon Converters, Inc.

view all

K811408 — STERILIZATION INDICATOR/SEAL PROTECTOR1981-06-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.