Device Classification Name |
Syringe, Piston
|
510(k) Number |
K160978 |
Device Name |
LITe BIO Delivery System |
Applicant |
STRYKER CORPORATION |
2 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Applicant Contact |
Meriam Gabera |
Correspondent |
STRYKER CORPORATION |
2 PEARL COURT |
ALLENDALE,
NJ
07401
|
|
Correspondent Contact |
Meriam Gabera |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 04/07/2016 |
Decision Date | 07/08/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|