The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Synthes Reusable Sterilization Container System.
| Device ID | K130720 |
| 510k Number | K130720 |
| Device Name: | SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | SYNTHES (USA) PRODUCTS LLC 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Thomas Shea |
| Correspondent | Thomas Shea SYNTHES (USA) PRODUCTS LLC 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-18 |
| Decision Date | 2014-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679620190350 | K130720 | 000 |
| H679620100050 | K130720 | 000 |
| H679620100040 | K130720 | 000 |
| H679620100030 | K130720 | 000 |
| H679620100020 | K130720 | 000 |
| H679620100010 | K130720 | 000 |
| H679620090210 | K130720 | 000 |
| H679620090100 | K130720 | 000 |
| H679620090050 | K130720 | 000 |
| H679620090040 | K130720 | 000 |
| H679620060200 | K130720 | 000 |
| H679620060100 | K130720 | 000 |
| H679620060030 | K130720 | 000 |
| H679620060020 | K130720 | 000 |
| H679620100060 | K130720 | 000 |
| H679620160010 | K130720 | 000 |
| H679620190340 | K130720 | 000 |
| H679620160330 | K130720 | 000 |
| H679620160320 | K130720 | 000 |
| H679620160310 | K130720 | 000 |
| H679620090350 | K130720 | 000 |
| H679620090340 | K130720 | 000 |
| H679620060330 | K130720 | 000 |
| H679620060320 | K130720 | 000 |
| H679620060310 | K130720 | 000 |
| H679620190050 | K130720 | 000 |
| H679620190040 | K130720 | 000 |
| H679620160030 | K130720 | 000 |
| H679620160020 | K130720 | 000 |
| H679620060010 | K130720 | 000 |