Cleared Traditional

K880998 - STERNUM SPREADER, PEDIATRIC
(FDA 510(k) Clearance)

K880998 · T. Korossurgical Instruments Corp. · General & Plastic Surgery device

Mar 1988

Decision

13d

Days

Class 1

Risk

K880998 is an FDA 510(k) clearance for the STERNUM SPREADER, PEDIATRIC. 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 21, 1988, 13 days after receiving the submission on March 8, 1988.

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

Submission Details

510(k) Number	K880998 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 08, 1988
Decision Date	March 21, 1988
Days to Decision	13 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—