BOUNDARY SINGLE-USE CRANIOTOMY SHEET— 510(k) K820758

Name: FDA 510(k) clearance K820758
Creator: U.S. Food and Drug Administration
Published: 1982-04-29

Substantially Equivalent

The Buckeye Cellulose Corp.

FDA 510(k) clearance K820758 for BOUNDARY SINGLE-USE CRANIOTOMY SHEET, Substantially Equivalent on 1982-04-29. Applicant: The Buckeye Cellulose Corp.. Device class: 2.

Clearance details

Applicant: The Buckeye Cellulose Corp.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1982-03-22
Decision date: 1982-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

view all

K230645 — BeneHold Surgical Incise Drape with CHG antimicrobial II2023-10-25
K222578 — 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)2023-05-18
K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial2021-07-30
K200238 — ControlRad Sterile Cover2020-04-26
K163556 — MediClear PreOp2017-09-14

More clearances from The Buckeye Cellulose Corp.

view all

K822925 — BOUNDARY SINGLE-USE GOWNS1983-01-12
K823173 — ARRIRM SCRUB BRUSH/SPONGE1982-11-22
K821564 — BOUNDARY PROCESS CHANGE1982-07-02
K820116 — BOUNDARY1982-02-23
K813450 — BOUNDARY SINGLE-USE DRAPES1982-01-22

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