Device Classification Name |
apparatus, suction, ward use, portable, ac-powered
|
510(k) Number |
K944119 |
Device Name |
SURE-FLO IRRIGATION Y TUBING SET |
Applicant |
O.R. RESOURCES, INC. |
P.O. BOX 6563 |
ANNAPOLIS,
MD
21401
|
|
Applicant Contact |
STEVEN P LINDSEY |
Correspondent |
O.R. RESOURCES, INC. |
P.O. BOX 6563 |
ANNAPOLIS,
MD
21401
|
|
Correspondent Contact |
STEVEN P LINDSEY |
Regulation Number | 878.4780
|
Classification Product Code |
|
Date Received | 08/23/1994 |
Decision Date | 12/05/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|