POLYPOLE— 510(k) K861838

Substantially Equivalent

Poly Medical Technologies, Inc.

FDA 510(k) clearance K861838 for POLYPOLE, Substantially Equivalent on 1986-06-09. Applicant: Poly Medical Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Poly Medical Technologies, Inc.
Product code: Code FOX
Device class: Class 1
Regulation: 21 CFR 880.6990
Advisory panel: General Hospital
Date received: 1986-05-13
Decision date: 1986-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deephaven, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FOX

K980336 — IV STANDS1998-04-06
K964782 — MEDRAD CONTRAST HOLDER1997-02-25
K961470 — PORT-A-POLE1996-07-22
K960027 — HIGH VOLUME I.V. & IRRIGATION TOWER1996-03-12
K952196 — IV POLE/STAND1995-07-31

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