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510(k) K834027

Device
GOLD SEADS
Applicant
RADIATION SAFETY & NUCLEAR PRODUCTS, INC.
510(k) number
K834027
Product code
IWG  
Decision
Substantially Equivalent (SESE)
Decision date
1983-12-27
Date received
1983-11-22
Regulation
892.5730
Classification name
Seed, Isotope, Gold, Titanium, Platinum
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IWG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K081066BRACHYTHERAPY SOURCE DEVICE, MODEL 9011Medi-Physics, Inc., Dba GE Healthcare2008-05-05
K982421IMAGYN 125 I SEED, MODEL IS 125International Isotopes, Inc.1998-07-31

Legacy Summary#

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FDA Review#

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