ARTHROSCOPIC ELECTROSURGICAL PROBE

Arthroscope

SMITH & NEPHEW DYONICS, INC.

The following data is part of a premarket notification filed by Smith & Nephew Dyonics, Inc. with the FDA for Arthroscopic Electrosurgical Probe.

Pre-market Notification Details

Device IDK901505
510k NumberK901505
Device Name:ARTHROSCOPIC ELECTROSURGICAL PROBE
ClassificationArthroscope
Applicant SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover,  MA  01810
ContactEric Bannon
CorrespondentEric Bannon
SMITH & NEPHEW DYONICS, INC. 160 DASCOMB RD. Andover,  MA  01810
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-30
Decision Date1990-04-18

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