Device Classification Name |
light, surgical, fiberoptic
|
510(k) Number |
K875195 |
Device Name |
OPHTHALMIC LIGHT PIPE PICK |
Applicant |
TREK MEDICAL PRODUCTS, INC. |
P.O. BOX B, 820 SWAN DR. |
MUKWONAGO,
WI
53149
|
|
Applicant Contact |
KEVIN SINNETT |
Correspondent |
TREK MEDICAL PRODUCTS, INC. |
P.O. BOX B, 820 SWAN DR. |
MUKWONAGO,
WI
53149
|
|
Correspondent Contact |
KEVIN SINNETT |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 12/17/1987 |
Decision Date | 03/07/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|