Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K980400 |
Device Name |
PVRS-PEREGRINE VITREORETINAL SCISSOR MODEL PD505.10 |
Applicant |
PEREGRINE SURGICAL LTD. |
4050D SKYRON DR. |
DOYLESTOWN,
PA
18901
|
|
Applicant Contact |
TODD RICHMOND |
Correspondent |
PEREGRINE SURGICAL LTD. |
4050D SKYRON DR. |
DOYLESTOWN,
PA
18901
|
|
Correspondent Contact |
TODD RICHMOND |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 02/02/1998 |
Decision Date | 04/30/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|