Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K965127 |
Device Name |
DGH MODEL 9000 |
Applicant |
DGH TECHNOLOGY, INC. |
110 SUMMIT DR., SUITE B |
EXTON,
PA
19341
|
|
Applicant Contact |
EARL W HENDERSON |
Correspondent |
DGH TECHNOLOGY, INC. |
110 SUMMIT DR., SUITE B |
EXTON,
PA
19341
|
|
Correspondent Contact |
EARL W HENDERSON |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 12/23/1996 |
Decision Date | 03/17/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|