Device Classification Name |
Light, Surgical, Ceiling Mounted
|
510(k) Number |
K854922 |
Device Name |
AMSCO POLARIS SL |
Applicant |
AMSCO CO. |
2424 WEST 23RD ST. |
ERIE,
PA
16514
|
|
Applicant Contact |
JAMES A SPALLINA |
Correspondent |
AMSCO CO. |
2424 WEST 23RD ST. |
ERIE,
PA
16514
|
|
Correspondent Contact |
JAMES A SPALLINA |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 12/10/1985 |
Decision Date | 01/24/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|