Device Classification Name |
Pump, Portable, Aspiration (Manual Or Powered)
|
510(k) Number |
K926566 |
Device Name |
CARE-E-VAC |
Applicant |
AEROS INSTRUMENTS, INC. |
3411 COMMERCIAL AVE. |
NORTHBROOK,
IL
60062
|
|
Applicant Contact |
JAMES A KOPPA |
Correspondent |
AEROS INSTRUMENTS, INC. |
3411 COMMERCIAL AVE. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
JAMES A KOPPA |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 12/31/1992 |
Decision Date | 07/09/1993 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|