LORAD STEROLOC II

System, X-ray, Mammographic

LORAD CORP.

The following data is part of a premarket notification filed by Lorad Corp. with the FDA for Lorad Steroloc Ii.

Pre-market Notification Details

Device IDK952210
510k NumberK952210
Device Name:LORAD STEROLOC II
ClassificationSystem, X-ray, Mammographic
Applicant LORAD CORP. 36 APPLE RIDGE RD. Danbury,  CT  06810
ContactWally Orlow
CorrespondentWally Orlow
LORAD CORP. 36 APPLE RIDGE RD. Danbury,  CT  06810
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-10
Decision Date1995-07-24

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