The following data is part of a premarket notification filed by Reliance Medical Systems, Llc with the FDA for Reliance Buttress Washer System.
| Device ID | K073349 |
| 510k Number | K073349 |
| Device Name: | RELIANCE BUTTRESS WASHER SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Reliance Medical Systems, LLC 2647 CASSOWARY CIR Sandy, UT 84092 -7116 |
| Contact | Bret M Berry |
| Correspondent | Bret M Berry Reliance Medical Systems, LLC 2647 CASSOWARY CIR Sandy, UT 84092 -7116 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-29 |
| Decision Date | 2008-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842566106969 | K073349 | 000 |
| 00842566106952 | K073349 | 000 |
| 00842566106945 | K073349 | 000 |
| 00842566106938 | K073349 | 000 |