Device Classification Name |
pump, breast, powered
|
510(k) Number |
K950531 |
Device Name |
EGNELL ELITE |
Applicant |
HOLLISTER, INC. |
755 INDUSTRIAL DR. |
CARY,
IL
60013 -1993
|
|
Applicant Contact |
ROLAND MULLER |
Correspondent |
HOLLISTER, INC. |
755 INDUSTRIAL DR. |
CARY,
IL
60013 -1993
|
|
Correspondent Contact |
ROLAND MULLER |
Regulation Number | 884.5160
|
Classification Product Code |
|
Date Received | 02/07/1995 |
Decision Date | 09/22/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|