Cleared Traditional

STRIPE PROJECTOR

K902138 · Academic Catalyst Corp. · Ophthalmic

Jul 1990

Decision

56d

Days

Class 1

Risk

About This 510(k) Submission

K902138 is an FDA 510(k) clearance for the STRIPE PROJECTOR, a Lens, Fundus, Hruby, Diagnostic (Class I — General Controls, product code HJI), submitted by Academic Catalyst Corp. (Valhalla, US). The FDA issued a Cleared decision on July 5, 1990, 56 days after receiving the submission on May 10, 1990. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1395.

Submission Details

510(k) Number	K902138 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 1990
Decision Date	July 05, 1990
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—