Device Classification Name |
I.V. Start Kit
|
510(k) Number |
K922533 |
Device Name |
IV START KIT CUSTOM SMP # A-Z |
Applicant |
SPECIALTY MEDICAL PRODUCTS CO. |
1604 MERRILL DR. |
SUITE D |
LITTLE ROCK,
AK
72212
|
|
Applicant Contact |
JOHN LAMB |
Correspondent |
SPECIALTY MEDICAL PRODUCTS CO. |
1604 MERRILL DR. |
SUITE D |
LITTLE ROCK,
AK
72212
|
|
Correspondent Contact |
JOHN LAMB |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 05/28/1992 |
Decision Date | 03/23/1993 |
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
|