Device Classification Name |
Endoilluminator
|
510(k) Number |
K980530 |
Device Name |
PEREGRINE FIBER OPTIC BIPOLAR STRAIGHT PICK AND ANGLED PICK, MODELS PD100.12 AND PD100.13 |
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 | 876.1500
|
Classification Product Code |
|
Date Received | 02/11/1998 |
Decision Date | 05/12/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|