Cleared Traditional

OMS ANTERIOR CHAMBER INFUSION NEEDLE

K813483 · Optical Micro Systems, Inc. · Ophthalmic
Jan 1982
Decision
52d
Days
Risk

About This 510(k) Submission

K813483 is an FDA 510(k) clearance for the OMS ANTERIOR CHAMBER INFUSION NEEDLE, submitted by Optical Micro Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 22, 1982, 52 days after receiving the submission on December 1, 1981. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number K813483 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1981
Decision Date January 22, 1982
Days to Decision 52 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code
Device Class