Device Classification Name |
Light, Surgical, Ceiling Mounted
|
510(k) Number |
K122875 |
Device Name |
ORICARE L2700 |
Applicant |
ORICARE, INC. |
1900 AM DRIVE |
QUAKERTOWN,
PA
18951
|
|
Applicant Contact |
DAVID T JAMISON |
Correspondent |
ORICARE, INC. |
1900 AM DRIVE |
QUAKERTOWN,
PA
18951
|
|
Correspondent Contact |
DAVID T JAMISON |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 09/19/2012 |
Decision Date | 12/18/2012 |
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
|
|
|