| Device Classification Name |
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
|
| 510(k) Number |
K962920 |
| Device Name |
RENTON SUCTION DEVICE U.S. PATENT*4,767,404 |
| Applicant |
| R&S Surgical, LLC |
| 107 Tunnel Hill Rd. |
|
Georgetown,
IN
47122
|
|
| Applicant Contact |
DERRIC RENTON |
| Correspondent |
| R&S Surgical, LLC |
| 107 Tunnel Hill Rd. |
|
Georgetown,
IN
47122
|
|
| Correspondent Contact |
DERRIC RENTON |
| Regulation Number | 880.6740 |
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 07/26/1996 |
| Decision Date | 10/21/1996 |
| 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
|
|
|