Device Classification Name |
drill, surgical, ent (electric or pneumatic) including handpiece
|
510(k) Number |
K020594 |
Device Name |
DIEGO POWERED DISSECTOR AND DRILL SYSTEM |
Applicant |
GYRUS ENT L.L.C. |
2925 APPLING RD. |
BARTLETT,
TN
38133
|
|
Applicant Contact |
GREGORY SREDIN |
Correspondent |
GYRUS ENT L.L.C. |
2925 APPLING RD. |
BARTLETT,
TN
38133
|
|
Correspondent Contact |
GREGORY SREDIN |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 02/22/2002 |
Decision Date | 03/08/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|