Cleared Traditional

K921582 - FLOWERS MEDIAL MALAR IMPLANT
(FDA 510(k) Clearance)

K921582 · Implantech Associates, Inc. · General & Plastic Surgery

May 1992

Decision

34d

Days

Class 2

Risk

K921582 is an FDA 510(k) clearance for the FLOWERS MEDIAL MALAR IMPLANT. This device is classified as a Implant, Malar (Class II — Special Controls, product code LZK).

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 FDA review panel. Regulated under 21 CFR 878.3550.

Submission Details

510(k) Number	K921582 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