TURBINATE NASAL SPLINT

Splint, Intranasal Septal

SMITH & NEPHEW RICHARDS, INC.

The following data is part of a premarket notification filed by Smith & Nephew Richards, Inc. with the FDA for Turbinate Nasal Splint.

Pre-market Notification Details

Device IDK921202
510k NumberK921202
Device Name:TURBINATE NASAL SPLINT
ClassificationSplint, Intranasal Septal
Applicant SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactThomas Craig
CorrespondentThomas Craig
SMITH & NEPHEW RICHARDS, INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeLYA  
CFR Regulation Number874.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-03-12
Decision Date1992-07-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.