ABLATOR ELECTRODE

Arthroscope

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Ablator Electrode.

Pre-market Notification Details

Device IDK983652
510k NumberK983652
Device Name:ABLATOR ELECTRODE
ClassificationArthroscope
Applicant LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
ContactLaura D Seneff
CorrespondentLaura D Seneff
LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-19
Decision Date1999-03-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20845854035600 K983652 000
10845854035597 K983652 000
20845854035587 K983652 000
10845854035573 K983652 000
20845854027056 K983652 000
20845854027049 K983652 000
10845854027059 K983652 000
10845854027042 K983652 000
20845854029531 K983652 000

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