Cleared Traditional

K852330 - RETRACTOR, SURGICAL
(FDA 510(k) Clearance)

K852330 · Scholten Surgical Instruments, Inc. · General & Plastic Surgery device

Jun 1985

Decision

27d

Days

Class 1

Risk

K852330 is an FDA 510(k) clearance for the RETRACTOR, SURGICAL. This device is classified as a Retractor (Class I - General Controls, product code GAD).

Submitted by Scholten Surgical Instruments, Inc. (Redwood City, US). The FDA issued a Cleared decision on June 27, 1985, 27 days after receiving the submission on May 31, 1985.

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

Submission Details

510(k) Number	K852330 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 31, 1985
Decision Date	June 27, 1985
Days to Decision	27 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—