| Device Classification Name |
Catheter And Tip, Suction
|
| 510(k) Number |
K932138 |
| Device Name |
SALINE FOR IRRIGATION |
| Applicant |
| Rantran, Inc. |
| 2624 Beaver Glen Dr. |
|
Ashland,
VA
23005
|
|
| Applicant Contact |
ED RANSOM |
| Correspondent |
| Rantran, Inc. |
| 2624 Beaver Glen Dr. |
|
Ashland,
VA
23005
|
|
| Correspondent Contact |
ED RANSOM |
| Regulation Number | 880.6740 |
| Classification Product Code |
|
| Date Received | 04/21/1993 |
| Decision Date | 11/04/1994 |
| 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
|
|
|