Device Classification Name |
catheter, irrigation
|
510(k) Number |
K942273 |
Device Name |
ORION SUCTION CATHETER KIT WITH STERILE WATER |
Applicant |
REGULATORY & MARKETING SERVICES, INC. |
P.O. BOX 2308 |
1247 FLORIDA AVENUE |
PALM HARBOR,
FL
34682 -2308
|
|
Applicant Contact |
PATRICK LAMB |
Correspondent |
REGULATORY & MARKETING SERVICES, INC. |
P.O. BOX 2308 |
1247 FLORIDA AVENUE |
PALM HARBOR,
FL
34682 -2308
|
|
Correspondent Contact |
PATRICK LAMB |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 05/10/1994 |
Decision Date | 06/02/1994 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|