Device Classification Name |
lamp, operating-room
|
510(k) Number |
K993314 |
Device Name |
SYNTHES LIGHT GUIDE |
Applicant |
SYNTHES (USA) |
1303 GOSHEN PKWY. |
WAST CHESTER,
PA
19380
|
|
Applicant Contact |
JONATHAN GILBERT |
Correspondent |
SYNTHES (USA) |
1303 GOSHEN PKWY. |
WAST CHESTER,
PA
19380
|
|
Correspondent Contact |
JONATHAN GILBERT |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 10/04/1999 |
Decision Date | 12/06/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|