Cleared Traditional

BIO-PREP CEMENT RESTRICTOR

K931847 · Biomedical Devices, Inc. · Orthopedic

Jun 1994

Decision

441d

Days

Class 2

Risk

About This 510(k) Submission

K931847 is an FDA 510(k) clearance for the BIO-PREP CEMENT RESTRICTOR, a Cement Obturator (Class II — Special Controls, product code LZN), submitted by Biomedical Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on June 28, 1994, 441 days after receiving the submission on April 13, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number	K931847 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 13, 1993
Decision Date	June 28, 1994
Days to Decision	441 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Statement