The following data is part of a premarket notification filed by Sorin Group Italia S.r.l. with the FDA for Memo 4d.
| Device ID | K180411 |
| 510k Number | K180411 |
| Device Name: | MEMO 4D |
| Classification | Ring, Annuloplasty |
| Applicant | Sorin Group Italia S.r.l. Via Crescentino Sn Saluggia, IT 13040 |
| Contact | Mauro Ercolani |
| Correspondent | Mauro Ercolani Sorin Group Italia S.r.l. Via Crescentino Sn Saluggia, IT 13040 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-15 |
| Decision Date | 2018-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08022057015495 | K180411 | 000 |
| 08022057015419 | K180411 | 000 |
| 08022057015426 | K180411 | 000 |
| 08022057015433 | K180411 | 000 |
| 08022057015440 | K180411 | 000 |
| 08022057015457 | K180411 | 000 |
| 08022057015464 | K180411 | 000 |
| 08022057015471 | K180411 | 000 |
| 08022057015488 | K180411 | 000 |
| 08022057015402 | K180411 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MEMO 4D 79217857 5477959 Live/Registered |
SORIN GROUP ITALIA S.R.L. 2017-08-25 |