RADIONUCLIDE BRACHYTHERAPY SOURCE

Source, Brachytherapy, Radionuclide

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Radionuclide Brachytherapy Source.

Pre-market Notification Details

Device IDK093663
510k NumberK093663
Device Name:RADIONUCLIDE BRACHYTHERAPY SOURCE
ClassificationSource, Brachytherapy, Radionuclide
Applicant C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington,  GA  30014
ContactJulie Bassett
CorrespondentJulie Bassett
C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington,  GA  30014
Product CodeKXK  
CFR Regulation Number892.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-25
Decision Date2009-12-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00801741098697 K093663 000
00801741078309 K093663 000
00801741078293 K093663 000
00801741078279 K093663 000
00801741078262 K093663 000
00801741078231 K093663 000
00801741078224 K093663 000
00801741078217 K093663 000
00801741078200 K093663 000
00801741078316 K093663 000
00801741078323 K093663 000
00801741078330 K093663 000
00801741098604 K093663 000
00801741098598 K093663 000
00801741098376 K093663 000
00801741086779 K093663 000
00801741078378 K093663 000
00801741078361 K093663 000
00801741078354 K093663 000
00801741078347 K093663 000
00801741078194 K093663 000

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