| 510(k) Number |
K850152 |
| Device Name |
PRECONNECTED URETHRAL CATHETER TRAY |
| Applicant |
| Inmed Corp. |
| 3030-B Holcomb Bridge Rd. |
|
Norcross,
GA
30071
|
|
| Applicant Contact |
FLO BECKER |
| Correspondent |
| Inmed Corp. |
| 3030-B Holcomb Bridge Rd. |
|
Norcross,
GA
30071
|
|
| Correspondent Contact |
FLO BECKER |
| Date Received | 01/15/1985 |
| Decision Date | 03/12/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|