Cleared Traditional

K875289 - SUCTION RETRACTOR
(FDA 510(k) Clearance)

K875289 · T. Korossurgical Instruments Corp. · General & Plastic Surgery device

Jan 1988

Decision

23d

Days

Class 1

Risk

K875289 is an FDA 510(k) clearance for the SUCTION 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 January 22, 1988, 23 days after receiving the submission on December 30, 1987.

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

Submission Details

510(k) Number	K875289 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 30, 1987
Decision Date	January 22, 1988
Days to Decision	23 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—