Device Classification Name |
tape and bandage, adhesive
|
510(k) Number |
K940798 |
Device Name |
SHIPPERT PRESSURE BANDAGE |
Applicant |
DENVER SPLINT CO. |
7002 SOUTH REVERE PARKWAY, |
SUITE 60 |
ENGLEWOOD,
CO
80112
|
|
Applicant Contact |
SARAH M LAKE |
Correspondent |
DENVER SPLINT CO. |
7002 SOUTH REVERE PARKWAY, |
SUITE 60 |
ENGLEWOOD,
CO
80112
|
|
Correspondent Contact |
SARAH M LAKE |
Regulation Number | 880.5240
|
Classification Product Code |
|
Date Received | 02/22/1994 |
Decision Date | 09/28/1994 |
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
|
|
|