Cleared Traditional

K881156 - UNIVERSAL STERNUM SPREADER AND I.M.A. RETRACTOR
(FDA 510(k) Clearance)

K881156 · T. Korossurgical Instruments Corp. · General & Plastic Surgery device

Apr 1988

Decision

18d

Days

Class 1

Risk

K881156 is an FDA 510(k) clearance for the UNIVERSAL STERNUM SPREADER AND I.M.A. 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 April 5, 1988, 18 days after receiving the submission on March 18, 1988.

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

Submission Details

510(k) Number	K881156 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 18, 1988
Decision Date	April 05, 1988
Days to Decision	18 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—