Device Classification Name |
Dressing, Compression
|
510(k) Number |
K912765 |
Device Name |
STASIS BUTTON PRSSURE DEVICE |
Applicant |
ARCH DEVELOPMENT GROUP |
9648 OLIVE BLVD., SUITE 411 |
ST. LOUIS,
MO
63132
|
|
Applicant Contact |
ROBERT A ROTH |
Correspondent |
ARCH DEVELOPMENT GROUP |
9648 OLIVE BLVD., SUITE 411 |
ST. LOUIS,
MO
63132
|
|
Correspondent Contact |
ROBERT A ROTH |
Regulation Number | 880.5075
|
Classification Product Code |
|
Date Received | 06/24/1991 |
Decision Date | 08/12/1991 |
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
|
|
|