Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K852271 |
Device Name |
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001 |
Applicant |
COOPERVISION, INC. |
17701 COWAN AVE.P. O. BOX |
19587 |
IRVINE,
CA
92713
|
|
Applicant Contact |
DAVID W KRAPF |
Correspondent |
COOPERVISION, INC. |
17701 COWAN AVE.P. O. BOX |
19587 |
IRVINE,
CA
92713
|
|
Correspondent Contact |
DAVID W KRAPF |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 05/28/1985 |
Decision Date | 08/09/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|