Cleared Traditional

PHACO NEEDLES 1000-R & 1000-O NEEDLES

K923630 · O.R. Specialties, Inc. · Ophthalmic
Apr 1994
Decision
624d
Days
Class 2
Risk

About This 510(k) Submission

K923630 is an FDA 510(k) clearance for the PHACO NEEDLES 1000-R & 1000-O NEEDLES, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by O.R. Specialties, Inc. (Tuscaloosa, US). The FDA issued a Cleared decision on April 6, 1994, 624 days after receiving the submission on July 21, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K923630 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1992
Decision Date April 06, 1994
Days to Decision 624 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HQC — Unit, Phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670

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