DIEGO POWERED DISSECTOR AND DRILL SYSTEM

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

GYRUS ENT L.L.C.

The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Diego Powered Dissector And Drill System.

Pre-market Notification Details

Device IDK020594
510k NumberK020594
Device Name:DIEGO POWERED DISSECTOR AND DRILL SYSTEM
ClassificationDrill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Applicant GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett,  TN  38133
ContactGregory Sredin
CorrespondentGregory Sredin
GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett,  TN  38133
Product CodeERL  
CFR Regulation Number874.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-22
Decision Date2002-03-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00821925042360 K020594 000
00821925011441 K020594 000
00821925011458 K020594 000
00821925026070 K020594 000
00821925026155 K020594 000
00821925026162 K020594 000
00821925026582 K020594 000
00821925028746 K020594 000
00821925026223 K020594 000
00821925026254 K020594 000
00821925026247 K020594 000
00821925026131 K020594 000
00821925027268 K020594 000
00821925011410 K020594 000

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