Device Classification Name |
Endoscope, Ac-Powered And Accessories
|
510(k) Number |
K896505 |
Device Name |
PORGES UNIVERSAL HANDLES |
Applicant |
PORGES CORP. |
5700 WEST 23RD AVE. |
GARY,
IN
46406
|
|
Applicant Contact |
HARRY M KAUFMAN |
Correspondent |
PORGES CORP. |
5700 WEST 23RD AVE. |
GARY,
IN
46406
|
|
Correspondent Contact |
HARRY M KAUFMAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/15/1989 |
Decision Date | 01/30/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|