Device Classification Name |
kit, surgical instrument, disposable
|
510(k) Number |
K960456 |
Device Name |
DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY |
Applicant |
DENVER BIOMATERIALS, INC. |
6851 HIGHWAY 73 |
EVERGREEN,
CO
80439
|
|
Applicant Contact |
LYNNE LEONARD |
Correspondent |
DENVER BIOMATERIALS, INC. |
6851 HIGHWAY 73 |
EVERGREEN,
CO
80439
|
|
Correspondent Contact |
LYNNE LEONARD |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 01/30/1996 |
Decision Date | 04/01/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|