Device Classification Name |
Kit, Surgical Instrument, Disposable
|
510(k) Number |
K011514 |
Device Name |
INSTRUMENTS FOR ONE TIME USE - DISPOSABLE |
Applicant |
KENCAP LTD. |
247 MARGARET KING AVE. |
RINGWOOD,
NJ
07456
|
|
Applicant Contact |
MARTY DELIN |
Correspondent |
KENCAP LTD. |
247 MARGARET KING AVE. |
RINGWOOD,
NJ
07456
|
|
Correspondent Contact |
MARTY DELIN |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 05/17/2001 |
Decision Date | 08/13/2001 |
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
|