PNEUMATIC CUTTER SYSTEM

Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

SURGICAL LASER TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Pneumatic Cutter System.

Pre-market Notification Details

Device IDK983050
510k NumberK983050
Device Name:PNEUMATIC CUTTER SYSTEM
ClassificationDrill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Applicant SURGICAL LASER TECHNOLOGIES, INC. 147 KEYSTONE DR. Montgomeryville,  PA  18936
ContactMonica Ferrante
CorrespondentMonica Ferrante
SURGICAL LASER TECHNOLOGIES, INC. 147 KEYSTONE DR. Montgomeryville,  PA  18936
Product CodeERL  
CFR Regulation Number874.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-01
Decision Date1998-11-25
Summary:summary

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