Device Classification Name |
System, Peritoneal, Automatic Delivery
|
510(k) Number |
K822658 |
Device Name |
EXTENSION SET TYPE DP |
Applicant |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Correspondent |
ABBOTT LABORATORIES |
ONE ABBOTT PARK RD. |
ABBOTT PARK,
IL
60064 -3500
|
|
Regulation Number | 876.5630
|
Classification Product Code |
|
Date Received | 09/03/1982 |
Decision Date | 10/21/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|