Device Classification Name |
Surgeon'S Gloves
|
510(k) Number |
K121335 |
Device Name |
G-DERM POWDER-FREE SYNTHETIC SURGICAL GLOVE |
Applicant |
HUTCHINSON SANTE S.N.C. |
RUE MARRET PATUREL |
LIANCOURT,
FR
F-60140
|
|
Applicant Contact |
RAFFI KRIKORIAN |
Correspondent |
HUTCHINSON SANTE S.N.C. |
RUE MARRET PATUREL |
LIANCOURT,
FR
F-60140
|
|
Correspondent Contact |
RAFFI KRIKORIAN |
Regulation Number | 878.4460
|
Classification Product Code |
|
Date Received | 05/03/2012 |
Decision Date | 09/13/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|