Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K893003 |
Device Name |
TOCOLYTIC SITE CARE SUP KIT #1001/100A/CARRY CASE |
Applicant |
UNITED MEDICAL SYSTEMS, INC. |
1901 E. CARNEGIE AVE. |
SANTA ANA,
CA
92705
|
|
Applicant Contact |
GABREL DEUTSCH |
Correspondent |
UNITED MEDICAL SYSTEMS, INC. |
1901 E. CARNEGIE AVE. |
SANTA ANA,
CA
92705
|
|
Correspondent Contact |
GABREL DEUTSCH |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 04/24/1989 |
Decision Date | 07/14/1989 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|