Device Classification Name |
powered laser surgical instrument |
||||
---|---|---|---|---|---|
510(k) Number | K030423 | ||||
Device Name | POWERLITE 600 EP SYSTEM | ||||
Applicant |
|
||||
Applicant Contact | susan goldstein falk | ||||
Correspondent |
|
||||
Correspodent Contact | susan goldstein falk | ||||
Regulation Number | 878.4810 | ||||
Classification Product Code |
|
||||
Date Received | 02/10/2003 | ||||
Decision Date | 05/09/2003 | ||||
Decision |
substantially equivalent (SESE) |
||||
Regulation Medical Specialty |
General & Plastic Surgery |
||||
510k Review Panel |
General & Plastic Surgery |
||||
summary |
summary |
||||
Type | Traditional | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |