The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed R30 Silicone Assist Reservoir.
| Device ID | K882720 |
| 510k Number | K882720 |
| Device Name: | SCIMED R30 SILICONE ASSIST RESERVOIR |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis, MN 55441 |
| Contact | Swanson Lano |
| Correspondent | Swanson Lano SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis, MN 55441 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-01 |
| Decision Date | 1988-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30613994010446 | K882720 | 000 |
| 30613994010439 | K882720 | 000 |