Device Classification Name |
catheter and tip, suction
|
510(k) Number |
K934382 |
Device Name |
VCI SUCTION/IRRIGATION TUBING SET |
Applicant |
VITAL CONCEPTS, INC. |
4315 AIRWEST DR. S.E. |
GRAND RAPIDS,
MI
49512
|
|
Applicant Contact |
S. NICHOLAS AYOUB |
Correspondent |
VITAL CONCEPTS, INC. |
4315 AIRWEST DR. S.E. |
GRAND RAPIDS,
MI
49512
|
|
Correspondent Contact |
S. NICHOLAS AYOUB |
Regulation Number | 880.6740
|
Classification Product Code |
|
Date Received | 09/09/1993 |
Decision Date | 02/01/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|