Device Classification Name |
Pump, Infusion Or Syringe, Extra-Luminal
|
510(k) Number |
K931113 |
Device Name |
CADD-TPN(TM) AMBULATORY INFUSION SYSTEM |
Applicant |
PHARMACIA DELTEC, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Applicant Contact |
W NUMAINVILLE |
Correspondent |
PHARMACIA DELTEC, INC. |
1265 GREY FOX RD. |
ST. PAUL,
MN
55112
|
|
Correspondent Contact |
W NUMAINVILLE |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 03/04/1993 |
Decision Date | 04/28/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|