Device Classification Name |
light, surgical, ceiling mounted
|
510(k) Number |
K101537 |
Device Name |
AIM 200, MAJOR SURGICAL LIGHT |
Applicant |
BURTON MEDICAL PRODUCTS CORP. |
21100 LASSEN ST. |
CHATSWORTH,
CA
91311
|
|
Applicant Contact |
SCOT KINGHORN |
Correspondent |
BURTON MEDICAL PRODUCTS CORP. |
21100 LASSEN ST. |
CHATSWORTH,
CA
91311
|
|
Correspondent Contact |
SCOT KINGHORN |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 06/03/2010 |
Decision Date | 09/30/2010 |
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
|