CLOTHINGUARD— 510(k) K894760

Substantially Equivalent

Barrier Concepts, Inc.

FDA 510(k) clearance K894760 for CLOTHINGUARD, Substantially Equivalent on 1989-08-18. Applicant: Barrier Concepts, Inc.. Device class: 1.

Clearance details

Applicant: Barrier Concepts, Inc.
Product code: Code FYE
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1989-07-27
Decision date: 1989-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, SC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FYE

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K912790 — SURGICAL GOWN1991-09-19
K910920 — PROTEKT GLOVES1991-05-15
K910941 — LIFELINER SURGICAL GLOVE1991-05-09
K895667 — STERILE SURGICAL GOWN1989-10-13

More clearances from Barrier Concepts, Inc.

K894759 — ALLPAC(TM) MATERIAL1989-10-13

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