SEPTAL BUTTON

Button, Nasal Septal

XOMED, INC.

The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Septal Button.

Pre-market Notification Details

Device IDK781529
510k NumberK781529
Device Name:SEPTAL BUTTON
ClassificationButton, Nasal Septal
Applicant XOMED, INC. 1318 LONEDELL RD. Arnold,  MO  63010
Product CodeLFB  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-09-05
Decision Date1978-10-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00681490195348 K781529 000
00681490195331 K781529 000
00681490195317 K781529 000
00681490041942 K781529 000
00681490041935 K781529 000
00763000036119 K781529 000
00763000035693 K781529 000
00763000035686 K781529 000

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