Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K851211 |
Device Name |
PHACO PAK I |
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 | 06/05/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|