Cleared Traditional

EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD

K964855 · Shippert Medical Technologies Corp. · Ophthalmic
Mar 1997
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K964855 is an FDA 510(k) clearance for the EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD, a Sponge, Ophthalmic (Class II — Special Controls, product code HOZ), submitted by Shippert Medical Technologies Corp. (Englewood, US). The FDA issued a Cleared decision on March 4, 1997, 90 days after receiving the submission on December 4, 1996. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4790.

Submission Details

510(k) Number K964855 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1996
Decision Date March 04, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HOZ — Sponge, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4790

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