Cleared Traditional

K840416 - HEXCELITE (FDA 510(k) Clearance)

K840416 · Hexcel Medical · Physical Medicine device

Mar 1984

Decision

52d

Days

Class 1

Risk

K840416 is an FDA 510(k) clearance for the HEXCELITE. This device is classified as a Bandage, Cast (Class I - General Controls, product code ITG).

Submitted by Hexcel Medical (Mchenry, US). The FDA issued a Cleared decision on March 23, 1984, 52 days after receiving the submission on January 31, 1984.

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

Submission Details

510(k) Number	K840416 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 31, 1984
Decision Date	March 23, 1984
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—