Cleared Traditional

POSTERIOR CAPSULE SHIELD

K950798 · Oasis Medical, Inc. · Ophthalmic
May 1995
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K950798 is an FDA 510(k) clearance for the POSTERIOR CAPSULE SHIELD, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on May 22, 1995, 90 days after receiving the submission on February 21, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K950798 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1995
Decision Date May 22, 1995
Days to Decision 90 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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