Cleared Traditional

SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS

K950806 · Mira, Inc. · Ophthalmic

Jun 1996

Decision

469d

Days

Class 2

Risk

About This 510(k) Submission

K950806 is an FDA 510(k) clearance for the SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS, a Implant, Orbital, Extra-ocular (Class II — Special Controls, product code HQX), submitted by Mira, Inc. (Uxbridge, US). The FDA issued a Cleared decision on June 5, 1996, 469 days after receiving the submission on February 22, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.3340.

Submission Details

510(k) Number	K950806 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 22, 1995
Decision Date	June 05, 1996
Days to Decision	469 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF