Device Classification Name |
light, surgical, ceiling mounted
|
510(k) Number |
K072072 |
Device Name |
HARMONY LED-1 SURGICAL LIGHTING SYSTEM |
Applicant |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Applicant Contact |
JOHN SCOVILLE |
Correspondent |
STERIS Corporation |
5960 Heisley Road |
Mentor,
OH
44060
|
|
Correspondent Contact |
JOHN SCOVILLE |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 07/30/2007 |
Decision Date | 10/05/2007 |
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
|
Recalls |
CDRH Recalls
|