Cleared Traditional

K925583 - JOBSKIN CONTINUING CARE (FDA 510(k) Clearance)

K925583 · Jobst Institute, Inc. · General & Plastic Surgery device

Apr 1994

Decision

515d

Days

Class 1

Risk

K925583 is an FDA 510(k) clearance for the JOBSKIN CONTINUING CARE. This device is classified as a Elastomer, Silicone, For Scar Management (Class I - General Controls, product code MDA).

Submitted by Jobst Institute, Inc. (Toledo, US). The FDA issued a Cleared decision on April 4, 1994, 515 days after receiving the submission on November 5, 1992.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4025.

Submission Details

510(k) Number	K925583 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 05, 1992
Decision Date	April 04, 1994
Days to Decision	515 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF