VARIOUS DISPOSABLE SURGICAL GARMENTS— 510(k) K895235

Name: FDA 510(k) clearance K895235
Creator: U.S. Food and Drug Administration
Published: 1989-09-19

Substantially Equivalent

Protect Corp. of Indiana, Inc.

FDA 510(k) clearance K895235 for VARIOUS DISPOSABLE SURGICAL GARMENTS, Substantially Equivalent on 1989-09-19. Applicant: Protect Corp. of Indiana, Inc.. Device class: 1.

Clearance details

Applicant: Protect Corp. of Indiana, Inc.
Product code: Code FYE
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1989-08-07
Decision date: 1989-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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K910941 — LIFELINER SURGICAL GLOVE1991-05-09
K895667 — STERILE SURGICAL GOWN1989-10-13

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