SURGICAL GOWN— 510(k) K912790

Substantially Equivalent

Unicor Federal Dept. of Justice

FDA 510(k) clearance K912790 for SURGICAL GOWN, Substantially Equivalent on 1991-09-19. Applicant: Unicor Federal Dept. of Justice. Device class: 1.

Clearance details

Applicant: Unicor Federal Dept. of Justice
Product code: Code FYE
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1991-06-25
Decision date: 1991-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alderson, WV, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FYE

K932731 — BARRIER* EXTRA PROTECTION PLUS SURGICAL GOWN1994-04-11
K910920 — PROTEKT GLOVES1991-05-15
K910941 — LIFELINER SURGICAL GLOVE1991-05-09
K895667 — STERILE SURGICAL GOWN1989-10-13
K895235 — VARIOUS DISPOSABLE SURGICAL GARMENTS1989-09-19

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