Device Classification Name |
Pump, Infusion, Pca
|
510(k) Number |
K030661 |
Device Name |
STRYKER PAINPUMP2 |
Applicant |
STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Applicant Contact |
NICOLE PETTY |
Correspondent |
STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. |
KALAMAZOO,
MI
49001
|
|
Correspondent Contact |
NICOLE PETTY |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 03/03/2003 |
Decision Date | 05/30/2003 |
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
|
Recalls |
CDRH Recalls
|
|
|