Device Classification Name |
electrode, electrosurgical |
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---|---|---|---|---|
510(k) Number | K991830 | |||
Device Name | CAPSULAR SHRINKAGE ELECTRODE | |||
Applicant |
|
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Applicant Contact | laura seneff | |||
Correspondent |
|
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Correspodent Contact | laura seneff | |||
Regulation Number | 878.4400 | |||
Classification Product Code |
|
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Date Received | 05/28/1999 | |||
Decision Date | 08/20/1999 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General & Plastic Surgery |
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510k Review Panel |
General & Plastic Surgery |
|||
summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |