Cleared Traditional

OMS SILICONE OIL INJECTOR

K844895 · Optical Micro Systems, Inc. · Ophthalmic

Jun 1985

Decision

189d

Days

Class 3

Risk

About This 510(k) Submission

K844895 is an FDA 510(k) clearance for the OMS SILICONE OIL INJECTOR, a Fluid, Intraocular (Class III — Premarket Approval, product code LWL), submitted by Optical Micro Systems, Inc. (Danvers, US). The FDA issued a Cleared decision on June 24, 1985, 189 days after receiving the submission on December 17, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4275.

Submission Details

510(k) Number	K844895 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 1984
Decision Date	June 24, 1985
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—