VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE— 510(k) K945738

Name: FDA 510(k) clearance K945738
Creator: U.S. Food and Drug Administration
Published: 1995-02-14

Substantially Equivalent

Visitec Co.

FDA 510(k) clearance K945738 for VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE, Substantially Equivalent on 1995-02-14. Applicant: Visitec Co.. Device class: 2.

Clearance details

Applicant: Visitec Co.
Product code: Code HMT
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1994-11-23
Decision date: 1995-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

Download summary PDF View on FDA.gov ↗

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K942234 — VISITEC PRECISE-POINT1994-07-12
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Data sourced from openFDA. This site is unofficial and independent of the FDA.