Device Classification Name |
pump, infusion |
|||
---|---|---|---|---|
510(k) Number | K991936 | |||
Device Name | 3.0 ML RESERVOIR, MODEL 103/193 | |||
Applicant |
|
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Applicant Contact | jennifer lyons | |||
Correspondent |
|
|||
Correspodent Contact | jennifer lyons | |||
Regulation Number | 880.5725 | |||
Classification Product Code |
|
|||
Date Received | 06/09/1999 | |||
Decision Date | 01/18/2000 | |||
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 |