Device Classification Name |
Pump, Portable, Aspiration (Manual Or Powered)
|
510(k) Number |
K853909 |
Device Name |
EGNELL UNIVERSAL SUCTION PUMP |
Applicant |
EGNELL, INC. |
333 W. WACKER DR. |
SUITE 1900 |
CHICAGO,
IL
60606
|
|
Applicant Contact |
JOHN F LEMKER |
Correspondent |
EGNELL, INC. |
333 W. WACKER DR. |
SUITE 1900 |
CHICAGO,
IL
60606
|
|
Correspondent Contact |
JOHN F LEMKER |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 09/20/1985 |
Decision Date | 11/25/1985 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|