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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M6334289000 | K180528 | 000 |
| 00385640035187 | K180528 | 000 |
| 00385640039871 | K180528 | 000 |
| 00385640067041 | K180528 | 000 |
| 00385640069670 | K180528 | 000 |
| 00385640069663 | K180528 | 000 |
| 00385640069656 | K180528 | 000 |
| 00385640069649 | K180528 | 000 |
| 00385640069632 | K180528 | 000 |
| 00385640069625 | K180528 | 000 |
| 00385640069618 | K180528 | 000 |
| 00385640069601 | K180528 | 000 |
| 00385640041836 | K180528 | 000 |
| 00385640041829 | K180528 | 000 |
| 00385640035378 | K180528 | 000 |
| 00385640035170 | K180528 | 000 |
| 00385640041812 | K180528 | 000 |
| 00385640035194 | K180528 | 000 |
| 00385640035200 | K180528 | 000 |
| 00385640035217 | K180528 | 000 |
| 00385640039659 | K180528 | 000 |
| 00385640035361 | K180528 | 000 |
| 00385640035354 | K180528 | 000 |
| 00385640035347 | K180528 | 000 |
| 00385640035330 | K180528 | 000 |
| 00385640035323 | K180528 | 000 |
| 00385640035316 | K180528 | 000 |
| 00385640035309 | K180528 | 000 |
| 00385640035293 | K180528 | 000 |
| 00385640035286 | K180528 | 000 |
| 00385640035279 | K180528 | 000 |
| 00385640035262 | K180528 | 000 |
| 00385640035255 | K180528 | 000 |
| 00385640035248 | K180528 | 000 |
| 00385640035231 | K180528 | 000 |
| 00385640035224 | K180528 | 000 |
| 00385640041805 | K180528 | 000 |