NORLAND XR26 LATERAL SPINE OPTION

Densitometer, Bone

NORLAND CORP.

The following data is part of a premarket notification filed by Norland Corp. with the FDA for Norland Xr26 Lateral Spine Option.

Pre-market Notification Details

Device IDK902959
510k NumberK902959
Device Name:NORLAND XR26 LATERAL SPINE OPTION
ClassificationDensitometer, Bone
Applicant NORLAND CORP. W6340 HACKBARTH RD. Fort Atkinson,  WI  53538
ContactTerry Schwalenberg
CorrespondentTerry Schwalenberg
NORLAND CORP. W6340 HACKBARTH RD. Fort Atkinson,  WI  53538
Product CodeKGI  
CFR Regulation Number892.1170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-07-05
Decision Date1990-11-23

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