Device Classification Name |
illuminator, fiberoptic, surgical field |
||||
---|---|---|---|---|---|
510(k) Number | K021931 | ||||
Device Name | ENDOSCOPIC FIBEROPTIC CABLE | ||||
Original Applicant |
|
||||
Original Contact | marcelino afanador | ||||
Regulation Number | 878.4580 | ||||
Classification Product Code |
|
||||
Subsequent Product Code |
|
||||
Date Received | 06/12/2002 | ||||
Decision Date | 09/06/2002 | ||||
Decision |
substantially equivalent (SESE) |
||||
Regulation Medical Specialty |
General & Plastic Surgery |
||||
510k Review Panel |
General & Plastic Surgery |
||||
statement |
statement |
||||
Type | Traditional | ||||
Reviewed by Third Party | No | ||||
Combination Product |
No |