DIOMED 25 SURGICAL DIODE LASER, UROLOGY APPLICAT

Powered Laser Surgical Instrument

DIO-MED CORP.

The following data is part of a premarket notification filed by Dio-med Corp. with the FDA for Diomed 25 Surgical Diode Laser, Urology Applicat.

Pre-market Notification Details

Device IDK914520
510k NumberK914520
Device Name:DIOMED 25 SURGICAL DIODE LASER, UROLOGY APPLICAT
ClassificationPowered Laser Surgical Instrument
Applicant DIO-MED CORP. ST. JOHN'S INNOVATION PARK COWLEY ROAD Cambridge Cb4 4ws England,  GB
ContactIlkka Mannonen
CorrespondentIlkka Mannonen
DIO-MED CORP. ST. JOHN'S INNOVATION PARK COWLEY ROAD Cambridge Cb4 4ws England,  GB
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-10
Decision Date1993-01-22

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