DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE

Arthroscope

DYONICS, INC.

The following data is part of a premarket notification filed by Dyonics, Inc. with the FDA for Dyonics Disposable Arthroscopic Surgical Knife.

Pre-market Notification Details

Device IDK894728
510k NumberK894728
Device Name:DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFE
ClassificationArthroscope
Applicant DYONICS, INC. 160 DASCOMB RD. Andover,  MA  01810
ContactEric Bannon
CorrespondentEric Bannon
DYONICS, INC. 160 DASCOMB RD. Andover,  MA  01810
Product CodeHRX  
CFR Regulation Number888.1100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-26
Decision Date1989-08-18

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