Device Classification Name |
I.V. Start Kit
|
510(k) Number |
K852375 |
Device Name |
I.V. STARTER TRAY W/DYNADERM TRANSPARENT ADHESIVE |
Applicant |
FERRIS MFG. CORP. |
16W300 83RD ST. |
BURR RIDGE,
IL
60527 -5848
|
|
Applicant Contact |
CARL HAYS |
Correspondent |
FERRIS MFG. CORP. |
16W300 83RD ST. |
BURR RIDGE,
IL
60527 -5848
|
|
Correspondent Contact |
CARL HAYS |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 06/04/1985 |
Decision Date | 07/11/1985 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|