Cleared Traditional

K930675 - MITEK CONE WASHER (FDA 510(k) Clearance)

K930675 · Mitek Surgical Products, Inc. · General & Plastic Surgery device

Nov 1993

Decision

273d

Days

Class 1

Risk

K930675 is an FDA 510(k) clearance for the MITEK CONE WASHER. This device is classified as a Retention Device, Suture (Class I - General Controls, product code KGS).

Submitted by Mitek Surgical Products, Inc. (Norwood, US). The FDA issued a Cleared decision on November 9, 1993, 273 days after receiving the submission on February 9, 1993.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4930.

Submission Details

510(k) Number	K930675 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 09, 1993
Decision Date	November 09, 1993
Days to Decision	273 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement