Device Classification Name |
drill, surgical, ent (electric or pneumatic) including handpiece
|
510(k) Number |
K150969 |
Device Name |
Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces |
Applicant |
KARL STORZ ENDOSCOPY AMERICA, INC. |
2151 E. GRAND AVE |
EL SEGUNDO,
CA
90245
|
|
Applicant Contact |
Jennifer Michelle Chambers |
Correspondent |
KARL STORZ ENDOSCOPY AMERICA, INC. |
2151 E. GRAND AVE |
EL SEGUNDO,
CA
90245
|
|
Correspondent Contact |
Jennifer Michelle Chambers |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 04/13/2015 |
Decision Date | 01/08/2016 |
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
|