| Device Classification Name |
Device, Intravascular Catheter Securement
|
| 510(k) Number |
K822732 |
| Device Name |
LINEGUARD CATHETER SHIELD MODEL 100 |
| Applicant |
| Ray-Marshall Laboratory |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Ray-Marshall Laboratory |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 880.5210 |
| Classification Product Code |
|
| Date Received | 09/08/1982 |
| Decision Date | 09/24/1982 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|