DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES

Arthroscope

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Dyonics Disposable Endoscopic Surgery Blades.

Pre-market Notification Details

Device IDK970511
510k NumberK970511
Device Name:DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
ClassificationArthroscope
Applicant SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover,  MA  01810
ContactDeborah J Connors
CorrespondentDeborah J Connors
SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover,  MA  01810
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-11
Decision Date1997-08-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20885554009136 K970511 000
23596010477891 K970511 000
23596010408383 K970511 000

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