STRATA, MODEL V.O.95

System, Planning, Radiation Therapy Treatment

ROSSES MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Rosses Medical Systems with the FDA for Strata, Model V.o.95.

Pre-market Notification Details

Device IDK981678
510k NumberK981678
Device Name:STRATA, MODEL V.O.95
ClassificationSystem, Planning, Radiation Therapy Treatment
Applicant ROSSES MEDICAL SYSTEMS 10620 GUILFORD RD., STE. 201 Jessup,  MD  20794
ContactRene Spector
CorrespondentRene Spector
ROSSES MEDICAL SYSTEMS 10620 GUILFORD RD., STE. 201 Jessup,  MD  20794
Product CodeMUJ  
CFR Regulation Number892.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-12
Decision Date1998-12-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00852656007052 K981678 000

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