INTESTOPLANT— 510(k) K862412

Substantially Equivalent

Burron Medical Products, Inc.

FDA 510(k) clearance K862412 for INTESTOPLANT, Substantially Equivalent on 1986-11-13. Applicant: Burron Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Burron Medical Products, Inc.
Product code: Code LLD
Device class: Class 2
Regulation: 21 CFR 880.5965
Advisory panel: General Hospital
Date received: 1986-06-25
Decision date: 1986-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethlehem, PA, US

Download summary PDF View on FDA.gov ↗

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K841428 — JEJUNOSTOMY SET FOR TUBE FEEDING1984-07-09

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