Device Classification Name |
Laser, Ophthalmic
|
510(k) Number |
K061024 |
Device Name |
PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60 |
Applicant |
PEREGRINE SURGICAL LTD. |
51 BRITAIN DR. |
NEW BRITAIN,
PA
18901
|
|
Applicant Contact |
TODD RICHMOND |
Correspondent |
PEREGRINE SURGICAL LTD. |
51 BRITAIN DR. |
NEW BRITAIN,
PA
18901
|
|
Correspondent Contact |
TODD RICHMOND |
Regulation Number | 886.4390
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/13/2006 |
Decision Date | 06/21/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|