Device Classification Name |
Mesh, Surgical, Polymeric
|
510(k) Number |
K092224 |
FOIA Releasable 510(k) |
K092224
|
Device Name |
TIGR SURGICAL MESH , MODEL WK-6 |
Applicant |
NOVUS SCIENTIFIC PTE LTD |
NORDIC EUROPEAN CENTRE, 3 |
INTERNATIONAL BUSINESS PARK |
#01-20, SINGAPORE,
SG
609927
|
|
Applicant Contact |
KELVIN KOH |
Correspondent |
NOVUS SCIENTIFIC PTE LTD |
NORDIC EUROPEAN CENTRE, 3 |
INTERNATIONAL BUSINESS PARK |
#01-20, SINGAPORE,
SG
609927
|
|
Correspondent Contact |
KELVIN KOH |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 07/23/2009 |
Decision Date | 01/25/2010 |
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
|
Recalls |
CDRH Recalls
|
|
|