The following data is part of a premarket notification filed by Paragon Medical with the FDA for Stryker Universal Select Sterilization Tray System.
| Device ID | K173615 |
| 510k Number | K173615 |
| Device Name: | Stryker Universal Select Sterilization Tray System |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | Paragon Medical 8 Matchett Drive Pierceton, IN 46562 |
| Contact | Rebecca Walker |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2017-11-22 |
| Decision Date | 2018-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857387006039 | K173615 | 000 |
| 00857387006152 | K173615 | 000 |
| 00857387006169 | K173615 | 000 |
| 00857387006176 | K173615 | 000 |
| 00857387006183 | K173615 | 000 |
| 00857387006190 | K173615 | 000 |
| 00857387006206 | K173615 | 000 |
| 00857387006213 | K173615 | 000 |
| 00857387006220 | K173615 | 000 |
| 00857387006145 | K173615 | 000 |
| 00857387006138 | K173615 | 000 |
| 00857387006121 | K173615 | 000 |
| 00857387006046 | K173615 | 000 |
| 00857387006053 | K173615 | 000 |
| 00857387006060 | K173615 | 000 |
| 00857387006077 | K173615 | 000 |
| 00857387006084 | K173615 | 000 |
| 00857387006091 | K173615 | 000 |
| 00857387006107 | K173615 | 000 |
| 00857387006114 | K173615 | 000 |
| 00857387006237 | K173615 | 000 |
| 00857387006244 | K173615 | 000 |
| 00857387006367 | K173615 | 000 |
| 00857387006374 | K173615 | 000 |
| 00857387006381 | K173615 | 000 |
| 00857387006398 | K173615 | 000 |
| 00857387006404 | K173615 | 000 |
| 00857387006411 | K173615 | 000 |
| 00857387006978 | K173615 | 000 |
| 00857387006985 | K173615 | 000 |
| 00857387006350 | K173615 | 000 |
| 00857387006343 | K173615 | 000 |
| 00857387006336 | K173615 | 000 |
| 00857387006251 | K173615 | 000 |
| 00857387006268 | K173615 | 000 |
| 00857387006275 | K173615 | 000 |
| 00857387006282 | K173615 | 000 |
| 00857387006299 | K173615 | 000 |
| 00857387006305 | K173615 | 000 |
| 00857387006312 | K173615 | 000 |
| 00857387006329 | K173615 | 000 |
| 00857387006992 | K173615 | 000 |