Device Classification Name |
Apparatus, Electrosurgical
|
510(k) Number |
K153472 |
Device Name |
Quiver Laparoscopic Extendable |
Applicant |
ITL Corporation PTY LTD |
1/63 Wells Road |
Chelsea Heights, VIC,
AU
3196
|
|
Applicant Contact |
Emily Rossiter |
Correspondent |
Regulatory Resources, Inc. |
276 William Way |
Williamsburg,
VA
23185
|
|
Correspondent Contact |
Emily Rossiter |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 12/02/2015 |
Decision Date | 06/23/2016 |
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
|