Cleared Traditional

K852329 - STAND, OPERATING ROOM
(FDA 510(k) Clearance)

K852329 · Scholten Surgical Instruments, Inc. · General Hospital

Jun 1985

Decision

14d

Days

Class 1

Risk

K852329 is an FDA 510(k) clearance for the STAND, OPERATING ROOM. This device is classified as a Stand, Infusion (Class I - General Controls, product code FOX).

Submitted by Scholten Surgical Instruments, Inc. (Redwood City, US). The FDA issued a Cleared decision on June 14, 1985, 14 days after receiving the submission on May 31, 1985.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6990.

Submission Details

510(k) Number	K852329 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 31, 1985
Decision Date	June 14, 1985
Days to Decision	14 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—