The following data is part of a premarket notification filed by Sterile Containment Technology, Llc. with the FDA for One Tray Sealed Sterilization Container.
| Device ID | K052567 |
| 510k Number | K052567 |
| Device Name: | ONE TRAY SEALED STERILIZATION CONTAINER |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | STERILE CONTAINMENT TECHNOLOGY, LLC. 1301 QUARRY COURT, SUITE 204 Point Richmond, CA 94801 |
| Contact | Gage Garman |
| Correspondent | Gage Garman STERILE CONTAINMENT TECHNOLOGY, LLC. 1301 QUARRY COURT, SUITE 204 Point Richmond, CA 94801 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-19 |
| Decision Date | 2006-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859522006638 | K052567 | 000 |
| 00859522006102 | K052567 | 000 |
| 00859522006119 | K052567 | 000 |
| 00859522006126 | K052567 | 000 |
| 00859522006133 | K052567 | 000 |
| 00859522006140 | K052567 | 000 |
| 00859522006157 | K052567 | 000 |
| 00859522006409 | K052567 | 000 |
| 00859522006508 | K052567 | 000 |
| 00859522006515 | K052567 | 000 |
| 00859522006522 | K052567 | 000 |
| 00859522006539 | K052567 | 000 |
| 00859522006607 | K052567 | 000 |
| 00859522006614 | K052567 | 000 |
| 00859522006621 | K052567 | 000 |
| 00859522006010 | K052567 | 000 |