Device Classification Name |
Keratome, Ac-Powered
|
510(k) Number |
K984540 |
Device Name |
KERAVISION VACUUM RING SYSTEM |
Applicant |
KERAVISION, INC. |
555 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
HOWARD H HOLSTEIN |
Correspondent |
KERAVISION, INC. |
555 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
HOWARD H HOLSTEIN |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 12/21/1998 |
Decision Date | 04/28/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|