CARETEX SHOE COVERS— 510(k) K864550

Substantially Equivalent

James River Corp.

FDA 510(k) clearance K864550 for CARETEX SHOE COVERS, Substantially Equivalent on 1986-12-24. Applicant: James River Corp.. Device class: 1.

Clearance details

Applicant: James River Corp.
Product code: Code FXP
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1986-11-19
Decision date: 1986-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neenah, WI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FXP

K971076 — PRIMED SHOE COVERS, PRIMED HEAD COVERS1998-01-13
K971191 — FAR-EAST SHOE COVERS1997-07-10
K970815 — CONVERTORS IMPERVIOUS SHOE COVERS1997-03-27
K961342 — SHOE COVER, NON-STERILE1996-12-30
K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH1996-11-19

More clearances from James River Corp.

K894505 — COTOLIN DRAIN SPONGE AND DRESSING SPONGE1989-09-15
K894147 — VISULIN TRANSPARENT ADHESIVE DRESSING1989-08-09
K892580 — CARETOUCH EXAMINATION GLOVES1989-07-14
K893939 — ISOLATION MASKS1989-07-14
K894034 — MODIFIED LABELING OF SURGICAL GLOVES1989-07-14

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