Cleared Traditional

BRADBURY INTRAOCULAR RETINAL KIT CAT #200

K881049 · Microline Pentax, Inc. · Ophthalmic
Sep 1988
Decision
185d
Days
Class 1
Risk

About This 510(k) Submission

K881049 is an FDA 510(k) clearance for the BRADBURY INTRAOCULAR RETINAL KIT CAT #200, a Forceps, Ophthalmic (Class I — General Controls, product code HNR), submitted by Microline Pentax, Inc. (Devers, US). The FDA issued a Cleared decision on September 12, 1988, 185 days after receiving the submission on March 11, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K881049 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1988
Decision Date September 12, 1988
Days to Decision 185 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HNR — Forceps, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350