Device Classification Name |
needle, aspiration and injection, disposable
|
510(k) Number |
K994151 |
Device Name |
PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES |
Applicant |
XIMED/PROSURE/INJECTX |
2195 TRADE ZONE BLVD. |
SAN JOSE,
CA
95131
|
|
Applicant Contact |
LEE BUI |
Correspondent |
XIMED/PROSURE/INJECTX |
2195 TRADE ZONE BLVD. |
SAN JOSE,
CA
95131
|
|
Correspondent Contact |
LEE BUI |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 12/09/1999 |
Decision Date | 03/01/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|