Device Classification Name |
lens, fundus, hruby, diagnostic
|
510(k) Number |
K802927 |
Device Name |
SEBESTYEN IRRIGATING CONTACT LENS |
Applicant |
COOPER MEDICAL DEVICES CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
COOPER MEDICAL DEVICES CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.1395
|
Classification Product Code |
|
Date Received | 11/19/1980 |
Decision Date | 02/05/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|