The following data is part of a premarket notification filed by Ellipse Technologies, Incorporated with the FDA for Ellipse Supplemental Instrument Trays.
| Device ID | K151594 |
| 510k Number | K151594 |
| Device Name: | Ellipse Supplemental Instrument Trays |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Ellipse Technologies, Incorporated 13900 Alton Parkway, Suite 123 Irvine, CA 92618 |
| Contact | Cora Sim |
| Correspondent | Cora Sim Ellipse Technologies, Incorporated 13900 Alton Parkway, Suite 123 Irvine, CA 92618 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-12 |
| Decision Date | 2016-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887517055507 | K151594 | 000 |
| 00887517054302 | K151594 | 000 |
| 00887517030801 | K151594 | 000 |
| 00887517940339 | K151594 | 000 |