Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K891371 |
Device Name |
GILSDORF PERCU. ENDO.-PEG & PERCU. FLOURO.-PFG |
Applicant |
ENTECH, INC. |
ROUTE 22 EAST |
LEBANON,
NJ
08833
|
|
Applicant Contact |
LAURENCE A POTTER |
Correspondent |
ENTECH, INC. |
ROUTE 22 EAST |
LEBANON,
NJ
08833
|
|
Correspondent Contact |
LAURENCE A POTTER |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 03/09/1989 |
Decision Date | 08/03/1989 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|