Cleared Traditional

K922355 - POLLY'S VITREOUS SCISSORS J-225-S
(FDA 510(k) Clearance)

K922355 · O.R. Specialties, Inc. · Ophthalmic

Aug 1992

Decision

91d

Days

Class 2

Risk

K922355 is an FDA 510(k) clearance for the POLLY'S VITREOUS SCISSORS J-225-S, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by O.R. Specialties, Inc. (Tuscaloosa, US). The FDA issued a Cleared decision on August 18, 1992, 91 days after receiving the submission on May 19, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number	K922355 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 1992
Decision Date	August 18, 1992
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement