NIOMED SHOE COVERS— 510(k) K952897

Substantially Equivalent

Amerasia Corp.

FDA 510(k) clearance K952897 for NIOMED SHOE COVERS, Substantially Equivalent on 1995-10-23. Applicant: Amerasia Corp.. Device class: 1.

Clearance details

Applicant: Amerasia Corp.
Product code: Code FXP
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1995-06-23
Decision date: 1995-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baldwin Park, CA, 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 Amerasia Corp.

K955833 — NIOMED SURGICAL CAPS1996-03-15
K954747 — NIOMED BARRIER GOWNS1996-03-06
K954454 — NIOMED SURGICAL HOOD1996-01-23
K954455 — NIOMED BOUFFANT CAPS1996-01-23
K952937 — NIOMED NON-SKID SHOE COVERS1995-10-23

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