MODIFIED PALLADIUM SEED MODEL 100— 510(k) K874787

Name: FDA 510(k) clearance K874787
Creator: U.S. Food and Drug Administration
Published: 1987-12-22

Substantially Equivalent

Theragenics Corp.

FDA 510(k) clearance K874787 for MODIFIED PALLADIUM SEED MODEL 100, Substantially Equivalent on 1987-12-22. Applicant: Theragenics Corp.. Device class: 2.

Clearance details

Applicant: Theragenics Corp.
Product code: Code IWI
Device class: Class 2
Regulation: 21 CFR 892.5730
Advisory panel: Radiology
Date received: 1987-11-23
Decision date: 1987-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code IWI

view all

K973363 — NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL MED36331998-07-02
K940632 — I-125 RAPID STRAND1994-09-02
K912170 — RADIOACTIVE IODINE-125 SOURCES1991-08-09
K882449 — CESIUM 137 SOURCE, MODEL CSM-401989-04-14
K852542 — PALLADIUM SEED MODEL 1001986-01-14

More clearances from Theragenics Corp.

view all

K103319 — I-SEED2011-01-03
K072296 — POIINT OF CARE STRANDING SYSTEM, MODE 1004-002007-09-26
K043596 — THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S062005-01-26
K010283 — THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 2002001-04-26

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