Cleared Traditional

K900405 - SCHOLTEN FRAME
(FDA 510(k) Clearance)

K900405 · Scholten Surgical Instruments, Inc. · General & Plastic Surgery

Mar 1990

Decision

31d

Days

Class 1

Risk

K900405 is an FDA 510(k) clearance for the SCHOLTEN FRAME, a Table, Surgical With Orthopedic Accessories, Manual (Class I — General Controls, product code JEB), submitted by Scholten Surgical Instruments, Inc. (Oakland, US). The FDA issued a Cleared decision on March 1, 1990, 31 days after receiving the submission on January 29, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4950.

Submission Details

510(k) Number	K900405 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 1990
Decision Date	March 01, 1990
Days to Decision	31 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—