Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
|
510(k) Number |
K152744 |
Device Name |
DIEGO ELITE DRILL |
Applicant |
GYRUS ACMI, INC |
136 TURNPIKE ROAD |
SOUTHBOROUGH,
MA
01772
|
|
Applicant Contact |
DOLAN MILLS |
Correspondent |
GYRUS ACMI, INC |
136 TURNPIKE ROAD |
SOUTHBOROUGH,
MA
01772
|
|
Correspondent Contact |
DOLAN MILLS |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 09/23/2015 |
Decision Date | 06/10/2016 |
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
|
|
|