STERILE SURGICAL GOWN— 510(k) K895667

Substantially Equivalent

Clinitech, Inc.

FDA 510(k) clearance K895667 for STERILE SURGICAL GOWN, Substantially Equivalent on 1989-10-13. Applicant: Clinitech, Inc.. Device class: 1.

Clearance details

Applicant: Clinitech, Inc.
Product code: Code FYE
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1989-09-20
Decision date: 1989-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FYE

K932731 — BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN1994-04-11
K912790 — SURGICAL GOWN1991-09-19
K910920 — PROTEKT GLOVES1991-05-15
K910941 — LIFELINER SURGICAL GLOVE1991-05-09
K895235 — VARIOUS DISPOSABLE SURGICAL GARMENTS1989-09-19

More clearances from Clinitech, Inc.

K896367 — STERILE SURGICAL DRAPES AND SHEETS1989-12-04
K864311 — STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES)1986-11-26

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