NASAL SEPTAL 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 Nasal Septal Splint.

Pre-market Notification Details

Device IDK952207
510k NumberK952207
Device Name:NASAL SEPTAL SPLINT
ClassificationSplint, Intranasal Septal
Applicant SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett,  TN  38133
ContactAlicia Farage
CorrespondentAlicia Farage
SMITH & NEPHEW RICHARDS, INC. 2925 APPLING RD. Bartlett,  TN  38133
Product CodeLYA  
CFR Regulation Number874.4780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-10
Decision Date1995-06-07

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