XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT

Arthroscope

XOMED, INC.

The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Xomed Feathertouch Xps Power Rasp Attachment.

Pre-market Notification Details

Device IDK983025
510k NumberK983025
Device Name:XOMED FEATHERTOUCH XPS POWER RASP ATTACHMENT
ClassificationArthroscope
Applicant XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
ContactDebra N Cortner
CorrespondentDebra N Cortner
XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-08-31
Decision Date1998-11-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20681490051532 K983025 000
20681490051525 K983025 000
00681490051095 K983025 000
00681490051088 K983025 000
20681490049157 K983025 000

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