Device Classification Name |
Pump, Infusion Or Syringe, Extra-Luminal
|
510(k) Number |
K932055 |
Device Name |
PERCUPUMP II |
Applicant |
E-Z-EM, INC. |
717 MAIN ST. |
WESTBURY,
NY
11590
|
|
Applicant Contact |
MERRIBETH ADAMS |
Correspondent |
E-Z-EM, INC. |
717 MAIN ST. |
WESTBURY,
NY
11590
|
|
Correspondent Contact |
MERRIBETH ADAMS |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 04/28/1993 |
Decision Date | 03/21/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|