Cleared Traditional

CHIN WAFER

K921581 · Implantech Associates, Inc. · General & Plastic Surgery
May 1992
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K921581 is an FDA 510(k) clearance for the CHIN WAFER, a Prosthesis, Chin, Internal (Class II — Special Controls, product code FWP), submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on May 6, 1992, 34 days after receiving the submission on April 2, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.

Submission Details

510(k) Number K921581 FDA.gov
FDA Decision Cleared SESE
Date Received April 02, 1992
Decision Date May 06, 1992
Days to Decision 34 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FWP — Prosthesis, Chin, Internal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3550

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