Cleared Traditional

IMPLANTECH JEJ PERI-PYRIFORM IMPLANT

K962824 · Implantech Associates, Inc. · General & Plastic Surgery
Oct 1996
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K962824 is an FDA 510(k) clearance for the IMPLANTECH JEJ PERI-PYRIFORM IMPLANT, a Prosthesis, Nose, Internal (Class II — Special Controls, product code FZE), submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on October 3, 1996, 76 days after receiving the submission on July 19, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3680.

Submission Details

510(k) Number K962824 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1996
Decision Date October 03, 1996
Days to Decision 76 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FZE — Prosthesis, Nose, Internal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3680

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