The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Ths Instrument Tray.
| Device ID | K120947 |
| 510k Number | K120947 |
| Device Name: | THS INSTRUMENT TRAY |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough, MA 01752 |
| Contact | Sarah Fairfield |
| Correspondent | Sarah Fairfield 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 | 2012-03-29 |
| Decision Date | 2012-10-17 |
| Summary: | summary |