Device Classification Name |
instrument, surgical, disposable
|
510(k) Number |
K905240 |
Device Name |
VESSELOOPS |
Applicant |
SPARTA SURGICAL CORP. |
368 FAIRVIEW AVE. |
P.O. BOX 268 |
HAMMONTON,
NJ
08037
|
|
Applicant Contact |
CARLETON F KIMBER |
Correspondent |
SPARTA SURGICAL CORP. |
368 FAIRVIEW AVE. |
P.O. BOX 268 |
HAMMONTON,
NJ
08037
|
|
Correspondent Contact |
CARLETON F KIMBER |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 11/20/1990 |
Decision Date | 02/06/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|