| Device Classification Name |
set, administration, intravascular |
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|---|---|---|---|---|
| 510(k) Number | K021488 | |||
| Device Name | SURECAN SAFETY HUBER NEEDLE INFUSION SETS | |||
| Original Applicant |
|
|||
| Original Contact | sheri l masgnung | |||
| Regulation Number | 880.5440 | |||
| Classification Product Code |
|
|||
| Subsequent Product Code |
|
|||
| Date Received | 05/08/2002 | |||
| Decision Date | 07/08/2002 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
General Hospital |
|||
| 510k Review Panel |
General Hospital |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |