Cleared Traditional

STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT

K003954 · Biocomposites, Ltd. · Orthopedic
Jul 2001
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K003954 is an FDA 510(k) clearance for the STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT, a Filler, Bone Void, Calcium Compound (Class II — Special Controls, product code MQV), submitted by Biocomposites, Ltd. (Stoke On Trent, GB). The FDA issued a Cleared decision on July 12, 2001, 203 days after receiving the submission on December 21, 2000. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3045.

Submission Details

510(k) Number K003954 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2000
Decision Date July 12, 2001
Days to Decision 203 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MQV — Filler, Bone Void, Calcium Compound
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3045

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