Device Classification Name |
Lift, Patient, Ac-Powered
|
510(k) Number |
K121287 |
Device Name |
HT-WEDGE |
Applicant |
D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L |
513 SOUTH CLEWELL STREET |
BETHLEHEM,
PA
18015
|
|
Applicant Contact |
SUSAN PAVELKO |
Correspondent |
D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L |
513 SOUTH CLEWELL STREET |
BETHLEHEM,
PA
18015
|
|
Correspondent Contact |
SUSAN PAVELKO |
Regulation Number | 880.5500
|
Classification Product Code |
|
Date Received | 04/30/2012 |
Decision Date | 10/03/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|