Device Classification Name |
i.v. start kit
|
510(k) Number |
K914475 |
Device Name |
IV START KIT |
Applicant |
CYPRESS MEDICAL PRODUCTS, LTD. |
1202 SOUTH ROUTE 31 |
MCHENRY,
IL
60050
|
|
Applicant Contact |
VARUN SONI |
Correspondent |
CYPRESS MEDICAL PRODUCTS, LTD. |
1202 SOUTH ROUTE 31 |
MCHENRY,
IL
60050
|
|
Correspondent Contact |
VARUN SONI |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 10/08/1991 |
Decision Date | 03/18/1992 |
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
|
|
|