ASEP PLUS SURGICAL DRAPES— 510(k) K942294

Substantially Equivalent

Angelica Uniform

FDA 510(k) clearance K942294 for ASEP PLUS SURGICAL DRAPES, Substantially Equivalent on 1995-01-02. Applicant: Angelica Uniform. Device class: 2.

Clearance details

Applicant: Angelica Uniform
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1994-05-12
Decision date: 1995-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St Louis, MO, 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

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