Device Classification Name |
pump, portable, aspiration (manual or powered)
|
510(k) Number |
K941961 |
Device Name |
605 VACU-MAX |
Applicant |
MEDICAL INDUSTRIES AMERICA, INC. |
2879 R AVE. |
ADEL,
IA
50003 -8055
|
|
Applicant Contact |
MARK D HEBENSTREIT |
Correspondent |
MEDICAL INDUSTRIES AMERICA, INC. |
2879 R AVE. |
ADEL,
IA
50003 -8055
|
|
Correspondent Contact |
MARK D HEBENSTREIT |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 04/22/1994 |
Decision Date | 03/02/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|