510(k) K081066

Device: BRACHYTHERAPY SOURCE DEVICE, MODEL 9011
Applicant: MEDI-PHYSICS, INC., DBA GE HEALTHCARE
510(k) number: K081066
Product code: IWG
Decision: Substantially Equivalent (SESE)
Decision date: 2008-05-05
Date received: 2008-04-15
Regulation: 892.5730
Classification name: Seed, Isotope, Gold, Titanium, Platinum
Medical specialty: Radiology
Review panel: Radiology
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: DAVID RISLEY
Address: 101 Carnegie Centre Princeton NJ US 08540 08540

FDA Registration Numbers#

1054811

Source Documents#

Other 510(k) Records For Product Code IWG #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K982421	IMAGYN 125 I SEED, MODEL IS 125	International Isotopes, Inc.	1998-07-31
K834027	GOLD SEADS	Radiation Safety & Nuclear Products, Inc.	1983-12-27

Legacy Summary#

summary

FDA Review#

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