SDI SURGICAL DRAPE— 510(k) K833176

Substantially Equivalent

Sdi

FDA 510(k) clearance K833176 for SDI SURGICAL DRAPE, Substantially Equivalent on 1984-04-04. Applicant: Sdi. Device class: 2.

Clearance details

Applicant: Sdi
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1983-09-19
Decision date: 1984-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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

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