The following data is part of a premarket notification filed by Hologic, Inc. with the FDA for Myosure Intrument Tray.
| Device ID | K121280 |
| 510k Number | K121280 |
| Device Name: | MYOSURE INTRUMENT TRAY |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | HOLOGIC, INC. 250 CAMPUS DRIVE Marlborough, MA 01752 |
| Contact | Daniel F Phelan |
| Correspondent | Daniel F Phelan 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 | 2012-04-30 |
| Decision Date | 2013-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15420045510241 | K121280 | 000 |