Device Classification Name |
Photocoagulator And Accessories
|
510(k) Number |
K122997 |
Device Name |
23GA CURVED ILLUMINATING LASER PROBE |
Applicant |
PEREGRINE SURGICAL LTD. |
51 BRITAIN DR. |
NEW BRITAIN,
PA
18901
|
|
Applicant Contact |
RYAN O'LEARY |
Correspondent |
PEREGRINE SURGICAL LTD. |
51 BRITAIN DR. |
NEW BRITAIN,
PA
18901
|
|
Correspondent Contact |
RYAN O'LEARY |
Regulation Number | 886.4690
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/27/2012 |
Decision Date | 06/26/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|