Device Classification Name |
I.V. Start Kit
|
510(k) Number |
K923361 |
Device Name |
I.V. START KIT, STERILE, DISPOSABLE |
Applicant |
TRINITY LABORATORIES, INC. |
201 KILEY DR. |
SALISBURY,
MD
21801
|
|
Applicant Contact |
PARTHA BASUMALLIK |
Correspondent |
TRINITY LABORATORIES, INC. |
201 KILEY DR. |
SALISBURY,
MD
21801
|
|
Correspondent Contact |
PARTHA BASUMALLIK |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 07/08/1992 |
Decision Date | 06/28/1993 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|