Device Classification Name |
Apparatus, Suction, Ward Use, Portable, Ac-Powered
|
510(k) Number |
K081047 |
Device Name |
TRANSPOSAL ULTRA SYSTEMS |
Applicant |
DORNOCH MEDICAL SYSTEMS, INC. |
4032 WEST RIVERSIDE ST. |
RIVERSIDE,
MO
64150
|
|
Applicant Contact |
ANTHONY MARTINI |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DANIEL W LEHTONEN |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 04/14/2008 |
Decision Date | 04/29/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|