Device Classification Name |
Curette, Surgical, General Use
|
510(k) Number |
K902000 |
Device Name |
KEVTEK(TM) LASER DRAPE/ORGAN PROTECTOR/EYE SHIELD |
Applicant |
KEVTEK MEDICAL PRODUCTS, INC. |
P.O. BOX 580644 |
HOUSTON,
TX
77258
|
|
Applicant Contact |
WEINBERG, PHD |
Correspondent |
KEVTEK MEDICAL PRODUCTS, INC. |
P.O. BOX 580644 |
HOUSTON,
TX
77258
|
|
Correspondent Contact |
WEINBERG, PHD |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 05/02/1990 |
Decision Date | 08/21/1990 |
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
|
|
|