AXXENT SURFACE APPLICATOR, MODEL 710257

System, Therapeutic, X-ray

XOFT, INC.

The following data is part of a premarket notification filed by Xoft, Inc. with the FDA for Axxent Surface Applicator, Model 710257.

Pre-market Notification Details

Device IDK083734
510k NumberK083734
Device Name:AXXENT SURFACE APPLICATOR, MODEL 710257
ClassificationSystem, Therapeutic, X-ray
Applicant XOFT, INC. 345 POTRERO AVE. Sunnyvale,  CA  94085
ContactSteve Lin
CorrespondentSteve Lin
XOFT, INC. 345 POTRERO AVE. Sunnyvale,  CA  94085
Product CodeJAD  
CFR Regulation Number892.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-16
Decision Date2009-02-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858012005649 K083734 000
00858012005410 K083734 000
00858012005427 K083734 000
00858012005434 K083734 000
00858012005441 K083734 000
00858012005595 K083734 000
00858012005618 K083734 000
00858012005625 K083734 000
00858012005632 K083734 000
00858012005359 K083734 000

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