O.R. DRAPES— 510(k) K802797

Substantially Equivalent

Secol Co.

FDA 510(k) clearance K802797 for O.R. DRAPES, Substantially Equivalent on 1980-12-17. Applicant: Secol Co.. Device class: 2.

Clearance details

Applicant: Secol Co.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1980-11-04
Decision date: 1980-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

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 Secol Co.

K802790 — SOLVALINE1981-02-13
K810111 — CELLONA PLASTER VARNISH1981-02-04
K810109 — METAL SPLINTS1981-01-26
K810110 — COBBLER'S CHIP SPLINTS1981-01-26
K802794 — PRO-OPHTA STICKS1980-12-22

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