OVERSHOES (SURCHAUSSURES— 510(k) K851554

Substantially Equivalent

Roseburg SA

FDA 510(k) clearance K851554 for OVERSHOES (SURCHAUSSURES, Substantially Equivalent on 1985-04-30. Applicant: Roseburg SA. Device class: 1.

Clearance details

Applicant: Roseburg SA
Product code: Code FXP
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1985-04-16
Decision date: 1985-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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 Roseburg SA

K931155 — STAPLE, FIXATION BONE; SCREW FIXATION BONE1994-09-01
K890081 — CALIUS-ISABEL CANOVAS SUNGLASSES1989-03-09
K885275 — ASSENAT-BLESCHET SUNGLASSES1989-01-24
K882392 — BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES1988-08-26
K872715 — UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY1987-12-07

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