| Device Classification Name |
Tube, Aspirating, Flexible, Connecting
|
| 510(k) Number |
K960616 |
| Device Name |
VITAFLOW SUCTION/ASPIRATION TUBING SET |
| Applicant |
| Vital Concepts, Inc. |
| 5090 Kendrick Ct. SE |
|
Grand Rapids,
MI
49512
|
|
| Applicant Contact |
S. NICHOLAS AYOUB |
| Correspondent |
| Vital Concepts, Inc. |
| 5090 Kendrick Ct. SE |
|
Grand Rapids,
MI
49512
|
|
| Correspondent Contact |
S. NICHOLAS AYOUB |
| Regulation Number | 880.6740 |
| Classification Product Code |
|
| Date Received | 02/13/1996 |
| Decision Date | 05/06/1996 |
| 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
|
| Recalls |
CDRH Recalls
|
|
|