Device Classification Name |
accessories, catheter
|
510(k) Number |
K896087 |
Device Name |
PALESTRANT IRRIGATION AND DRAINAGE SET |
Applicant |
NORTH AMERICAN INSTRUMENT CORP. |
GLENS FALLS,
NY
12801
|
|
Applicant Contact |
ROBERT E FRANKLIN |
Correspondent |
NORTH AMERICAN INSTRUMENT CORP. |
GLENS FALLS,
NY
12801
|
|
Correspondent Contact |
ROBERT E FRANKLIN |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 10/19/1989 |
Decision Date | 11/03/1989 |
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
|