HOOD, OPERATING, SURGICAL— 510(k) K904969

Name: FDA 510(k) clearance K904969
Creator: U.S. Food and Drug Administration
Published: 1990-12-12

Substantially Equivalent

Chicago Assoc. For Retarded Citizens

FDA 510(k) clearance K904969 for HOOD, OPERATING, SURGICAL, Substantially Equivalent on 1990-12-12. Applicant: Chicago Assoc. For Retarded Citizens. Device class: 2.

Clearance details

Applicant: Chicago Assoc. For Retarded Citizens
Product code: Code FXY
Device class: Class 2
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1990-11-05
Decision date: 1990-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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Recent devices under product code FXY

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K222214 — ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)2023-10-17
K200493 — Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover2020-03-21
K140588 — FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS2014-06-26
K904276 — DISPOSABLE BEARD COVER1990-11-21
K903533 — STERI-SHIELD1990-10-19

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