MERTEX-PLUS REUSABLE SURGICAL DRAPE— 510(k) K012237

Substantially Equivalent

Mercan AB

FDA 510(k) clearance K012237 for MERTEX-PLUS REUSABLE SURGICAL DRAPE, Substantially Equivalent on 2001-10-15. Applicant: Mercan AB. Device class: 2.

Clearance details

Applicant: Mercan AB
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2001-07-17
Decision date: 2001-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKX

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K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial2021-07-30
K200238 — ControlRad Sterile Cover2020-04-26
K163556 — MediClear PreOp2017-09-14

More clearances from Mercan AB

K012240 — MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE2001-10-15

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