SURGICAL APPAREL SHOE COVERS— 510(k) K831952

Name: FDA 510(k) clearance K831952
Creator: U.S. Food and Drug Administration
Published: 1983-07-12

Substantially Equivalent

Sudreca Surgical Dressings, Inc.

FDA 510(k) clearance K831952 for SURGICAL APPAREL SHOE COVERS, Substantially Equivalent on 1983-07-12. Applicant: Sudreca Surgical Dressings, Inc.. Device class: 1.

Clearance details

Applicant: Sudreca Surgical Dressings, Inc.
Product code: Code BWP
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1983-06-15
Decision date: 1983-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BWP

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K880384 — KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT1988-06-23
K812105 — ANOGO DISPOSABLE SHOE COVER1981-09-11

More clearances from Sudreca Surgical Dressings, Inc.

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K832172 — GAUZE SPONGE X-RAY DETECTABLE-1983-08-12
K832173 — GAUZE SPONGE STERILE1983-08-12
K832174 — GAUZE SPONGE NON-STERILE1983-08-12

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