Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K873729 |
Device Name |
RATE-MATE NITROGLYCERIN I.V. ADMINISTRATION SET |
Applicant |
CRITIKON COMPANY,LLC |
4110 GEORGE RD. |
P.O. BOX 22800 |
TAMPA,
FL
33630
|
|
Applicant Contact |
RAYMOND E URSICK |
Correspondent |
CRITIKON COMPANY,LLC |
4110 GEORGE RD. |
P.O. BOX 22800 |
TAMPA,
FL
33630
|
|
Correspondent Contact |
RAYMOND E URSICK |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 09/15/1987 |
Decision Date | 12/29/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|