The following data is part of a premarket notification filed by Restore Medical Solutions, Inc. with the FDA for Restore Modular Sterilization Tray System.
| Device ID | K131455 |
| 510k Number | K131455 |
| Device Name: | RESTORE MODULAR STERILIZATION TRAY SYSTEM |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | RESTORE MEDICAL SOLUTIONS, INC. 5600 WISCONSIN AVE. #509 Chevy Chase, MD 20815 |
| Contact | Patsy J Trisler |
| Correspondent | Patsy J Trisler RESTORE MEDICAL SOLUTIONS, INC. 5600 WISCONSIN AVE. #509 Chevy Chase, MD 20815 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-20 |
| Decision Date | 2013-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860190001498 | K131455 | 000 |
| 00860190001412 | K131455 | 000 |
| 00860190001429 | K131455 | 000 |
| 00860190001436 | K131455 | 000 |
| 00860190001443 | K131455 | 000 |
| 00860190001450 | K131455 | 000 |
| 00860190001467 | K131455 | 000 |
| 00860190001474 | K131455 | 000 |
| 00860190001481 | K131455 | 000 |
| 00860190001405 | K131455 | 000 |