Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K850182 |
Device Name |
IVAC KEOFEED II POLYURETHANE FEEDING TUBE |
Applicant |
Y |
P.O. BOX 85335 |
SAN DIEGO,
CA
92138 -5335
|
|
Applicant Contact |
ALBERT P PEDO |
Correspondent |
Y |
P.O. BOX 85335 |
SAN DIEGO,
CA
92138 -5335
|
|
Correspondent Contact |
ALBERT P PEDO |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 01/18/1985 |
Decision Date | 03/19/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|