Device Classification Name |
Kit, Surgical Instrument, Disposable
|
510(k) Number |
K874063 |
Device Name |
ENTERON ABDOMINAL PARACENTESIS TRAY |
Applicant |
ENDOVATIONS |
895 POPLAR CHURCH RD. |
CAMP HILL,
PA
17011
|
|
Applicant Contact |
SUSAN P BJORKMAN |
Correspondent |
ENDOVATIONS |
895 POPLAR CHURCH RD. |
CAMP HILL,
PA
17011
|
|
Correspondent Contact |
SUSAN P BJORKMAN |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 10/05/1987 |
Decision Date | 12/04/1987 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|