Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K851210 |
Device Name |
UNITED SONICS PHACO MODULE, DF-35 |
Applicant |
UNITED SONICS, INC. |
180 VANDERBILT MOTOR PKWY. |
HAUPPAUGE,
NY
11788
|
|
Applicant Contact |
JOSEPH SPINOSA |
Correspondent |
UNITED SONICS, INC. |
180 VANDERBILT MOTOR PKWY. |
HAUPPAUGE,
NY
11788
|
|
Correspondent Contact |
JOSEPH SPINOSA |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 03/26/1985 |
Decision Date | 05/31/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|