Device Classification Name |
light, surgical, floor standing
|
510(k) Number |
K880198 |
Device Name |
GEMINI SURGICAL LIGHT |
Applicant |
AMERICAN STERILIZER CO. |
2222 WEST GRANDVIEW BLVD. |
ERIE,
PA
16512
|
|
Applicant Contact |
JAMES A SPALLINA |
Correspondent |
AMERICAN STERILIZER CO. |
2222 WEST GRANDVIEW BLVD. |
ERIE,
PA
16512
|
|
Correspondent Contact |
JAMES A SPALLINA |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 01/15/1988 |
Decision Date | 02/10/1988 |
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
|