Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K921127 |
Device Name |
PANDA NEEDLE CATHETER JEJUNOSTOMY KIT |
Applicant |
KNIGHT MEDICAL, INC. |
320 CHARLES ST. |
CAMBRIDGE,
MA
02141
|
|
Applicant Contact |
DAVID KREIDER |
Correspondent |
KNIGHT MEDICAL, INC. |
320 CHARLES ST. |
CAMBRIDGE,
MA
02141
|
|
Correspondent Contact |
DAVID KREIDER |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 03/10/1992 |
Decision Date | 01/04/1993 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|