MEDIFIX— 510(k) K813498

Substantially Equivalent

Burron Medical Products, Inc.

FDA 510(k) clearance K813498 for MEDIFIX, Substantially Equivalent on 1982-01-07. Applicant: Burron Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Burron Medical Products, Inc.
Product code: Code KRK
Device class: Class 2
Regulation: 21 CFR 870.1140
Advisory panel: Cardiovascular
Date received: 1981-12-14
Decision date: 1982-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRK

K950607 — UST-5268P-5 TRANSDUCER1995-09-15
K904674 — CENTRAL VENOUS PRESSURE MANOMETER1990-12-27
K884386 — ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK1989-01-05
K875322 — MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER1988-03-28
K861605 — SCHNEIDER-SHILEY PRESSURE MANOMETER1986-05-28

More clearances from Burron Medical Products, Inc.

K870403 — CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE1987-05-01
K862412 — INTESTOPLANT1986-11-13
K861479 — CAVAFIX, CENTRAL VENOUS CATHETER KIT1986-07-01
K860126 — STIMUPLEX, NERVE STIMULATOR1986-02-28
K851293 — IMPLANTOFIX1986-01-09

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