Device Classification Name |
tape, camera, surgical
|
510(k) Number |
K070426 |
Device Name |
SILHOUETTE, MODEL 1000.01 |
Applicant |
ARANZ MEDICAL LIMITED |
GROUND FLOOR ST ELMO COURTS |
47 HEREFORD ST. PO BOX 3894 |
CHRISTCHURCH, CANTERBURY,
NZ
8013
|
|
Applicant Contact |
SHANE GOODWIN |
Correspondent |
ARANZ MEDICAL LIMITED |
GROUND FLOOR ST ELMO COURTS |
47 HEREFORD ST. PO BOX 3894 |
CHRISTCHURCH, CANTERBURY,
NZ
8013
|
|
Correspondent Contact |
SHANE GOODWIN |
Regulation Number | 878.4160
|
Classification Product Code |
|
Date Received | 02/13/2007 |
Decision Date | 06/29/2007 |
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
|
|
|