Cleared Traditional

K904909 - I/A VITROPHAGE MODEL YPR 2001
(FDA 510(k) Clearance)

K904909 · Visioncare Devices, Inc. · Ophthalmic

Jan 1991

Decision

89d

Days

Class 2

Risk

K904909 is an FDA 510(k) clearance for the I/A VITROPHAGE MODEL YPR 2001, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Visioncare Devices, Inc. (Redding, US). The FDA issued a Cleared decision on January 28, 1991, 89 days after receiving the submission on October 31, 1990. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number	K904909 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 31, 1990
Decision Date	January 28, 1991
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—