Cleared Traditional

K890167 - HOLDER, NEEDLE (FDA 510(k) Clearance)

K890167 · Dhason Brothers, Inc. · Orthopedic device

Feb 1989

Decision

25d

Days

Class 1

Risk

K890167 is an FDA 510(k) clearance for the HOLDER, NEEDLE. This device is classified as a Holder, Needle; Orthopedic (Class I - General Controls, product code HXK).

Submitted by Dhason Brothers, Inc. (Hyattsville, US). The FDA issued a Cleared decision on February 3, 1989, 25 days after receiving the submission on January 9, 1989.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number	K890167 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 09, 1989
Decision Date	February 03, 1989
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—