Device Classification Name |
bronchoscope (flexible or rigid)
|
510(k) Number |
K895948 |
Device Name |
PORT-O-SCOPE(TM) |
Applicant |
NORTH AMERICAN MEDICAL PRODUCTS, INC. |
6 WHITE FIR DR. |
LOUDONVILLE,
NY
12211
|
|
Applicant Contact |
ARTHUR GIANAKOS |
Correspondent |
NORTH AMERICAN MEDICAL PRODUCTS, INC. |
6 WHITE FIR DR. |
LOUDONVILLE,
NY
12211
|
|
Correspondent Contact |
ARTHUR GIANAKOS |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 10/10/1989 |
Decision Date | 03/27/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|