Device Classification Name |
Light, Surgical, Fiberoptic
|
510(k) Number |
K071218 |
Device Name |
PROXENON 350, MODEL 902XX |
Applicant |
WELCH ALLYN, INC. |
4341 STATE STREET ROAD |
PO BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Applicant Contact |
JOHN E SAWYER |
Correspondent |
WELCH ALLYN, INC. |
4341 STATE STREET ROAD |
PO BOX 220 |
SKANEATELES FALLS,
NY
13153 -0220
|
|
Correspondent Contact |
JOHN E SAWYER |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 05/02/2007 |
Decision Date | 06/14/2007 |
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
|