Device Classification Name |
Needle, Aspiration And Injection, Disposable
|
510(k) Number |
K102274 |
Device Name |
ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT |
Applicant |
ARVIK ENTERPRISES/ MINI LAP TECHNOLOGIES |
80 SHELTON TECHNOLOGY CENTER |
SHELTON,
CT
06484
|
|
Applicant Contact |
CURTIS RAYMOND |
Correspondent |
ARVIK ENTERPRISES/ MINI LAP TECHNOLOGIES |
80 SHELTON TECHNOLOGY CENTER |
SHELTON,
CT
06484
|
|
Correspondent Contact |
CURTIS RAYMOND |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 08/11/2010 |
Decision Date | 06/15/2011 |
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
|