Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K883097 |
Device Name |
GV3000 PHACOEMULSIFIER/FRAGMENTER |
Applicant |
D.O.R.C. INTL. B.V. |
STEPHEN W. WEBB |
87 RUMFORD AVENUE |
WALTHAM,
MA
02154
|
|
Applicant Contact |
MIRA, INC. |
Correspondent |
D.O.R.C. INTL. B.V. |
STEPHEN W. WEBB |
87 RUMFORD AVENUE |
WALTHAM,
MA
02154
|
|
Correspondent Contact |
MIRA, INC. |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 07/22/1988 |
Decision Date | 12/06/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|