Cleared Traditional

K896792 - SURGICAL SKIN MARKER
(FDA 510(k) Clearance)

K896792 · Westmark, Sterile Packing Systems, Inc. (Sps) · General & Plastic Surgery device

Dec 1989

Decision

26d

Days

Class 1

Risk

K896792 is an FDA 510(k) clearance for the SURGICAL SKIN MARKER. This device is classified as a Marker, Skin (Class I - General Controls, product code FZZ).

Submitted by Westmark, Sterile Packing Systems, Inc. (Sps) (Grand Rapids, US). The FDA issued a Cleared decision on December 27, 1989, 26 days after receiving the submission on December 1, 1989.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4660.

Submission Details

510(k) Number	K896792 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 01, 1989
Decision Date	December 27, 1989
Days to Decision	26 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—