FAR-EAST SHOE COVERS— 510(k) K971191

Name: FDA 510(k) clearance K971191
Creator: U.S. Food and Drug Administration
Published: 1997-07-10

Substantially Equivalent

Far East Science & Technology Development Co., Ltd.

FDA 510(k) clearance K971191 for FAR-EAST SHOE COVERS, Substantially Equivalent on 1997-07-10. Applicant: Far East Science & Technology Development Co., Ltd.. Device class: 1.

Clearance details

Applicant: Far East Science & Technology Development Co., Ltd.
Product code: Code FXP
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1997-03-31
Decision date: 1997-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, CA, US

Download summary PDF View on FDA.gov ↗

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K971076 — PRIMED SHOE COVERS, PRIMED HEAD COVERS1998-01-13
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K961342 — SHOE COVER, NON-STERILE1996-12-30
K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH1996-11-19
K952897 — NIOMED SHOE COVERS1995-10-23

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K970988 — FAR-EAST BOUFFANT CAPS1997-07-10
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Data sourced from openFDA. This site is unofficial and independent of the FDA.