The following data is part of a premarket notification filed by Hologic, Inc with the FDA for Omni Instrument Tray.
| Device ID | K182052 |
| 510k Number | K182052 |
| Device Name: | Omni Instrument Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Hologic, Inc 250 Campus Drive Marlborough, MA 01752 |
| Contact | Rachelle D. Fitzgerald |
| Correspondent | Rachelle D. Fitzgerald Hologic, Inc 250 Campus Drive Marlborough, MA 01752 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-31 |
| Decision Date | 2019-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045510296 | K182052 | 000 |
| 15420045516595 | K182052 | 000 |