Cleared Traditional

K811754 - CRYSTONA (FDA 510(k) Clearance)

K811754 · Smith & Nephew, Inc. · Physical Medicine device

Jul 1981

Decision

28d

Days

Class 1

Risk

K811754 is an FDA 510(k) clearance for the CRYSTONA. This device is classified as a Bandage, Cast (Class I - General Controls, product code ITG).

Submitted by Smith & Nephew, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1981, 28 days after receiving the submission on June 22, 1981.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3025.

Submission Details

510(k) Number	K811754 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 22, 1981
Decision Date	July 20, 1981
Days to Decision	28 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—

Device Classification

Product Code	ITG — Bandage, Cast
Device Class	Class I - General Controls
CFR Regulation	21 CFR 890.3025