Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K952468 |
Device Name |
HI-LINE MEDICAL PHACOEMULSIFIER TIP |
Applicant |
HI-LINE MEDICAL |
23461 RIDGE ROUTE |
SUITE I |
LAGUNA HILLS,
CA
92653
|
|
Applicant Contact |
GLENN A DUNKI-JACOBS |
Correspondent |
HI-LINE MEDICAL |
23461 RIDGE ROUTE |
SUITE I |
LAGUNA HILLS,
CA
92653
|
|
Correspondent Contact |
GLENN A DUNKI-JACOBS |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 05/26/1995 |
Decision Date | 08/24/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|