The following data is part of a premarket notification filed by Summit Medical Inc. with the FDA for Instrusafe(r) Sterilization Container.
| Device ID | K180528 |
| 510k Number | K180528 |
| Device Name: | InstruSafe(R) Sterilization Container |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Summit Medical Inc. 815 Northwest Parkway, Suite 100 St. Paul, MN 55121 |
| Contact | Nicole Dove |
| Correspondent | Nicole Dove Summit Medical Inc. 815 Northwest Parkway, Suite 100 St. Paul, MN 55121 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-28 |
| Decision Date | 2018-11-16 |
| Summary: | summary |