Device Classification Name |
monitor, electric for gravity flow infusion systems
|
510(k) Number |
K022248 |
Device Name |
STRYKER L3 HYDROLERT |
Applicant |
Stryker Endoscopy |
5900 OPTICAL CT. |
SAN JOSE,
CA
95138
|
|
Applicant Contact |
MICHAEL HILLDOERFER |
Correspondent |
Stryker Endoscopy |
5900 OPTICAL CT. |
SAN JOSE,
CA
95138
|
|
Correspondent Contact |
MICHAEL HILLDOERFER |
Regulation Number | 880.2420
|
Classification Product Code |
|
Date Received | 07/12/2002 |
Decision Date | 08/06/2002 |
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
|
|
|