HEEL/ELBOW PROTECTOR— 510(k) K771913

Substantially Equivalent

Alba-Waldensian, Inc.

FDA 510(k) clearance K771913 for HEEL/ELBOW PROTECTOR, Substantially Equivalent on 1977-11-15. Applicant: Alba-Waldensian, Inc.. Device class: 1.

Clearance details

Applicant: Alba-Waldensian, Inc.
Product code: Code FMP
Device class: Class 1
Regulation: 21 CFR 880.6450
Advisory panel: General Hospital
Date received: 1977-10-11
Decision date: 1977-11-15
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 Alba-Waldensian, Inc.

K020592 — ALBAHEALTH C.A.L.M. SLEEVE, MODEL 590012002-04-03
K961405 — ALBA HEALTH PAS WRAP SYSTEM1996-12-26
K852091 — ALBA DRY BURN PAD1985-06-13
K792357 — STERILE IMPERVIOUS ORTHOPEDIC STOCKIN1979-12-18
K781964 — COMPRESSION DEVICES, LIMB1978-12-12

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