Cleared Special

SURGIFORM ANATOMICAL MALAR

K983756 · Surgical Technology Laboratories, Inc. · General & Plastic Surgery
Nov 1998
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K983756 is an FDA 510(k) clearance for the SURGIFORM ANATOMICAL MALAR, a Implant, Malar (Class II — Special Controls, product code LZK), submitted by Surgical Technology Laboratories, Inc. (Cleveland, US). The FDA issued a Cleared decision on November 20, 1998, 29 days after receiving the submission on October 22, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.

Submission Details

510(k) Number K983756 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1998
Decision Date November 20, 1998
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

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

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