Cleared Traditional

K896473 - H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR
(FDA 510(k) Clearance)

K896473 · Emory University School of Medicine · Ophthalmic
Feb 1990
Decision
88d
Days
Class 1
Risk

K896473 is an FDA 510(k) clearance for the H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR, a Magnet, Permanent (Class I — General Controls, product code HPN), submitted by Emory University School of Medicine (Atlanta, US). The FDA issued a Cleared decision on February 9, 1990, 88 days after receiving the submission on November 13, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4445.

Submission Details

510(k) Number K896473 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1989
Decision Date February 09, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HPN — Magnet, Permanent
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4445