Cleared Traditional

HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER

K961511 · Lifecore Biomedical, Inc. · General & Plastic Surgery
Jun 1996
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K961511 is an FDA 510(k) clearance for the HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER, a Implant, Malar (Class II — Special Controls, product code LZK), submitted by Lifecore Biomedical, Inc. (Chaska, US). The FDA issued a Cleared decision on June 28, 1996, 70 days after receiving the submission on April 19, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.

Submission Details

510(k) Number K961511 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1996
Decision Date June 28, 1996
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LZK — Implant, Malar
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3550

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