Device Classification Name |
Apparatus, Air Handling, Enclosure
|
510(k) Number |
K854159 |
Device Name |
ELLIPTI-PUNCH |
Applicant |
ALCON LABORATORIES |
6201 SOUTH FREEWAY |
R7-14 |
FORT WORTH,
TX
76134 -2099
|
|
Applicant Contact |
REBECCA G WALKER |
Correspondent |
ALCON LABORATORIES |
6201 SOUTH FREEWAY |
R7-14 |
FORT WORTH,
TX
76134 -2099
|
|
Correspondent Contact |
REBECCA G WALKER |
Regulation Number | 878.5070
|
Classification Product Code |
|
Date Received | 10/11/1985 |
Decision Date | 11/15/1985 |
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
|