MEDI PLUS SURGEON'S GLOVES— 510(k) K945363

Name: FDA 510(k) clearance K945363
Creator: U.S. Food and Drug Administration
Published: 1995-03-07

Substantially Equivalent

P.T. Saptindo Surgica

FDA 510(k) clearance K945363 for MEDI PLUS SURGEON'S GLOVES, Substantially Equivalent on 1995-03-07. Applicant: P.T. Saptindo Surgica. Device class: 1.

Clearance details

Applicant: P.T. Saptindo Surgica
Product code: Code KGO
Device class: Class 1
Regulation: 21 CFR 878.4460
Advisory panel: General, Plastic Surgery
Date received: 1994-10-19
Decision date: 1995-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck,, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.