Device Classification Name |
powered laser surgical instrument |
|||
---|---|---|---|---|
510(k) Number | K992083 | |||
Device Name | SCATTERFREE LATERAL EMITTING FIBER | |||
Applicant |
|
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Applicant Contact | nancy l arnold | |||
Correspondent |
|
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Correspodent Contact | nancy l arnold | |||
Regulation Number | 878.4810 | |||
Classification Product Code |
|
|||
Date Received | 06/21/1999 | |||
Decision Date | 07/12/1999 | |||
Decision |
substantially equivalent (SESE) |
|||
Regulation Medical Specialty |
General & Plastic Surgery |
|||
510k Review Panel |
General & Plastic Surgery |
|||
statement |
statement |
|||
Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |