Cleared Traditional

K880813 - SELF-RETAINING SOFT TISSUE RETRACTOR
(FDA 510(k) Clearance)

K880813 · T. Korossurgical Instruments Corp. · General & Plastic Surgery device

Mar 1988

Decision

14d

Days

Class 1

Risk

K880813 is an FDA 510(k) clearance for the SELF-RETAINING SOFT TISSUE RETRACTOR. This device is classified as a Retractor (Class I - General Controls, product code GAD).

Submitted by T. Korossurgical Instruments Corp. (Moorepark, US). The FDA issued a Cleared decision on March 11, 1988, 14 days after receiving the submission on February 26, 1988.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K880813 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 26, 1988
Decision Date	March 11, 1988
Days to Decision	14 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—