Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K133788 |
Device Name |
COOK HOLMIUM LASER FIBER |
Applicant |
COOK INCORPORATED |
750 DANIELS WAY |
BLOOMINGTON,
IN
47402
|
|
Applicant Contact |
DAVID CHADWICK |
Correspondent |
COOK INCORPORATED |
750 DANIELS WAY |
BLOOMINGTON,
IN
47402
|
|
Correspondent Contact |
DAVID CHADWICK |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 12/12/2013 |
Decision Date | 03/18/2015 |
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
|