Device Classification Name |
syringe, piston |
|||
---|---|---|---|---|
510(k) Number | K021084 | |||
Device Name | LIGHT SABER SPINAL NEEDLE | |||
Original Applicant |
|
|||
Original Contact | kim s devito | |||
Regulation Number | 880.5860 | |||
Classification Product Code |
|
|||
Subsequent Product Code |
|
|||
Date Received | 04/04/2002 | |||
Decision Date | 07/03/2002 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General Hospital |
|||
510k Review Panel |
Radiology |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |