Cleared Traditional

PROSTHETIC CEMENT REMOVER

K890285 · Albert K. Chin · Orthopedic

Apr 1989

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K890285 is an FDA 510(k) clearance for the PROSTHETIC CEMENT REMOVER, a System, Cement Removal Extraction (Class II — Special Controls, product code LZV), submitted by Albert K. Chin (Portola Valley, US). The FDA issued a Cleared decision on April 19, 1989, 90 days after receiving the submission on January 19, 1989. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4580.

Submission Details

510(k) Number	K890285 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 19, 1989
Decision Date	April 19, 1989
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—