The following data is part of a premarket notification filed by Itl Corporation Pty Ltd with the FDA for Quiver Laparoscopic Extendable.
| Device ID | K153472 |
| 510k Number | K153472 |
| Device Name: | Quiver Laparoscopic Extendable |
| Classification | Apparatus, Electrosurgical |
| Applicant | ITL Corporation PTY LTD 1/63 Wells Road Chelsea Heights, Vic, AU 3196 |
| Contact | Emily Rossiter |
| Correspondent | Emily Rossiter Regulatory Resources, Inc. 276 William Way Williamsburg, VA 23185 |
| Product Code | HAM |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-02 |
| Decision Date | 2016-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 19555240400748 | K153472 | 000 |
| 19555240400946 | K153472 | 000 |