EXTEND FRAME SYSTEM, MODEL 1009633

System, Radiation Therapy, Radionuclide

ELEKTA INSTRUMENT AB

The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Extend Frame System, Model 1009633.

Pre-market Notification Details

Device IDK092083
510k NumberK092083
Device Name:EXTEND FRAME SYSTEM, MODEL 1009633
ClassificationSystem, Radiation Therapy, Radionuclide
Applicant ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm,  SE S-103 93
ContactAbders Skoglund
CorrespondentAbders Skoglund
ELEKTA INSTRUMENT AB KUNGSTENSGATAN 18 P.O.BOX 7593 Stockholm,  SE S-103 93
Product CodeIWB  
CFR Regulation Number892.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-07-09
Decision Date2009-09-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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07340048305495 K092083 000
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07340048306720 K092083 000
07340048306713 K092083 000
07340048306706 K092083 000
07340048304580 K092083 000

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