Device Classification Name |
apparatus, suction, single patient use, portable, nonpowered
|
510(k) Number |
K850011 |
Device Name |
PROVAC WOUND HEALING/SUCTION SET |
Applicant |
MEDICAL MATRIX, INC. |
P.O. BOX 429378 |
CINCINNATI,
OH
45242
|
|
Applicant Contact |
F CIAFARDINI |
Correspondent |
MEDICAL MATRIX, INC. |
P.O. BOX 429378 |
CINCINNATI,
OH
45242
|
|
Correspondent Contact |
F CIAFARDINI |
Regulation Number | 878.4680
|
Classification Product Code |
|
Date Received | 01/02/1985 |
Decision Date | 05/21/1985 |
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
|
|
|