HEEL/ELBOW PROTECTORS— 510(k) K791709

Substantially Equivalent

Fibre Formations, Inc.

FDA 510(k) clearance K791709 for HEEL/ELBOW PROTECTORS, Substantially Equivalent on 1979-09-24. Applicant: Fibre Formations, Inc.. Device class: 1.

Clearance details

Applicant: Fibre Formations, Inc.
Product code: Code FMP
Device class: Class 1
Regulation: 21 CFR 880.6450
Advisory panel: General Hospital
Date received: 1979-08-27
Decision date: 1979-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMP

K150243 — Invictus Medical GelShield2015-05-01
K951325 — COMFEEL PLUS PRESSURE RELIEF DRESSING1995-07-31
K934731 — MEDSURG STERILE IMAGING PRODUCTS1994-03-28
K820584 — DECUBICARE PADS & ACCESSORIES1982-03-25
K812344 — HEEL OR ELBOW PROTECTOR1981-09-11

More clearances from Fibre Formations, Inc.

K790922 — DISPOSABLE ADULT DIAPER1979-07-30
K781930 — PANT LINER, DISP. INCONTINENT1979-02-01
K781233 — IV ARMBOARDS1978-08-14
K781246 — FOAM COMFORT RINGS1978-08-10

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