MENTOR SUPER ABSORBENT DRAPE— 510(k) K973146

Name: FDA 510(k) clearance K973146
Creator: U.S. Food and Drug Administration
Published: 1997-12-04

Substantially Equivalent

Mentor Ophthalmics, Inc.

FDA 510(k) clearance K973146 for MENTOR SUPER ABSORBENT DRAPE, Substantially Equivalent on 1997-12-04. Applicant: Mentor Ophthalmics, Inc.. Device class: 2.

Clearance details

Applicant: Mentor Ophthalmics, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1997-08-22
Decision date: 1997-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, 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 Mentor Ophthalmics, Inc.

view all

K971538 — MENTOR GEMINI HEMOSTATIC ERASER1997-07-14
K964312 — MENTOR TONO-PEN 31996-11-26
K960765 — MENTOR ADVENT A/B SYSTEM1996-08-08

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