Device Classification Name |
Cystotome
|
510(k) Number |
K871365 |
Device Name |
CAPSULECTOMER CYSTOTOME |
Applicant |
NOETIX, INC. |
5670 N. MERIDIAN |
INDIANAPOLIS,
IN
46208
|
|
Applicant Contact |
JOSEPH L MARK |
Correspondent |
NOETIX, INC. |
5670 N. MERIDIAN |
INDIANAPOLIS,
IN
46208
|
|
Correspondent Contact |
JOSEPH L MARK |
Regulation Number | 886.4350
|
Classification Product Code |
|
Date Received | 04/07/1987 |
Decision Date | 04/16/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|