The following data is part of a premarket notification filed by O&m Halyard, Inc with the FDA for Sterisystem Dry-base Instrument Tray.
| Device ID | K203177 |
| 510k Number | K203177 |
| Device Name: | Sterisystem Dry-Base Instrument Tray |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | O&M Halyard, Inc 1 Edison Drive Alpharetta, GA 30005 |
| Contact | Steven Dowdley |
| Correspondent | Steven Dowdley O&M Halyard, Inc 1 Edison Drive Alpharetta, GA 30005 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-26 |
| Decision Date | 2022-01-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651479229 | K203177 | 000 |
| 90680651474295 | K203177 | 000 |
| 90680651474288 | K203177 | 000 |
| 90680651474264 | K203177 | 000 |
| 90680651474257 | K203177 | 000 |
| 90680651474196 | K203177 | 000 |
| 90680651474189 | K203177 | 000 |
| 90680651474172 | K203177 | 000 |
| 90680651474165 | K203177 | 000 |
| 90680651474141 | K203177 | 000 |
| 90680651474301 | K203177 | 000 |
| 90680651474318 | K203177 | 000 |
| 90680651474325 | K203177 | 000 |
| 30680651479212 | K203177 | 000 |
| 30680651479205 | K203177 | 000 |
| 30680651479199 | K203177 | 000 |
| 30680651479182 | K203177 | 000 |
| 30680651479175 | K203177 | 000 |
| 30680651479168 | K203177 | 000 |
| 30680651479151 | K203177 | 000 |
| 30680651479144 | K203177 | 000 |
| 90680651474424 | K203177 | 000 |
| 90680651474134 | K203177 | 000 |