Device Classification Name |
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
|
510(k) Number |
K990038 |
Device Name |
HUMMER TRAK SYSTEM |
Applicant |
Stryker Endoscopy |
2590 WALSH AVE. |
SANTA CLARA,
CA
95051 -4085
|
|
Applicant Contact |
DAVID HIMES |
Correspondent |
Stryker Endoscopy |
2590 WALSH AVE. |
SANTA CLARA,
CA
95051 -4085
|
|
Correspondent Contact |
DAVID HIMES |
Regulation Number | 874.4250
|
Classification Product Code |
|
Date Received | 01/06/1999 |
Decision Date | 02/19/1999 |
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
|
|
|