Cleared Traditional

BIO-PREP

K931846 · Biomedical Devices, Inc. · Orthopedic
Jan 1994
Decision
283d
Days
Class 1
Risk

About This 510(k) Submission

K931846 is an FDA 510(k) clearance for the BIO-PREP, a Orthopedic Manual Surgical Instrument (Class I — General Controls, product code LXH), submitted by Biomedical Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on January 21, 1994, 283 days after receiving the submission on April 13, 1993. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K931846 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1993
Decision Date January 21, 1994
Days to Decision 283 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

Product Code LXH — Orthopedic Manual Surgical Instrument
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4540

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