NEEDLE GUIDE

System, X-ray, Mammographic

REMINGTON MEDICAL, INC.

The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Needle Guide.

Pre-market Notification Details

Device IDK983621
510k NumberK983621
Device Name:NEEDLE GUIDE
ClassificationSystem, X-ray, Mammographic
Applicant REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE CT. Alpharetta,  GA  30005
ContactSteve Woody
CorrespondentSteve Woody
REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE CT. Alpharetta,  GA  30005
Product CodeIZH  
CFR Regulation Number892.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-15
Decision Date1998-11-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10813079020421 K983621 000
20813079020411 K983621 000
10813079020407 K983621 000

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