Device Classification Name |
tape and bandage, adhesive
|
510(k) Number |
K915358 |
Device Name |
PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH |
Applicant |
MEDTRONIC VASCULAR |
6700 SHINGLE CREEK PKY |
BROOKLYN CENTER,
MN
55430
|
|
Applicant Contact |
DAVID MUELLER |
Correspondent |
MEDTRONIC VASCULAR |
6700 SHINGLE CREEK PKY |
BROOKLYN CENTER,
MN
55430
|
|
Correspondent Contact |
DAVID MUELLER |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 11/27/1991 |
Decision Date | 04/28/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|