Cleared Traditional

VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE

K945738 · Visitec Co. · General Hospital
Feb 1995
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K945738 is an FDA 510(k) clearance for the VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE, a Drape, Patient, Ophthalmic (Class II — Special Controls, product code HMT), submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on February 14, 1995, 83 days after receiving the submission on November 23, 1994. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K945738 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 1994
Decision Date February 14, 1995
Days to Decision 83 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code HMT — Drape, Patient, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4370