Cleared Traditional

MODIFICATION TO SKVEKPATCH

K984177 · Marine Polymer Technologies, Inc. · General & Plastic Surgery

Dec 1998

Decision

28d

Days

Class 1

Risk

About This 510(k) Submission

K984177 is an FDA 510(k) clearance for the MODIFICATION TO SKVEKPATCH, a Bandage, Liquid (Class I — General Controls, product code KMF), submitted by Marine Polymer Technologies, Inc. (Danvers, US). The FDA issued a Cleared decision on December 18, 1998, 28 days after receiving the submission on November 20, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number	K984177 FDA.gov
FDA Decision	Cleared SN
Date Received	November 20, 1998
Decision Date	December 18, 1998
Days to Decision	28 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—