The following data is part of a premarket notification filed by Rp Medical, Inc. with the FDA for Pivot System Sterilization Case.
| Device ID | K181845 |
| 510k Number | K181845 |
| Device Name: | Pivot System Sterilization Case |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | RP Medical, Inc. 22715 Holyrood Avenue Maple Ridge, CA V2x 6e7 |
| Contact | Jim Barley |
| Correspondent | Jim Barley RP Medical, Inc. 22715 Holyrood Avenue Maple Ridge, CA V2x 6e7 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-11 |
| Decision Date | 2019-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850032955003 | K181845 | 000 |