The following data is part of a premarket notification filed by Peters Surgical with the FDA for Uniring - Annuloplasty Ring With Sizers.
| Device ID | K071281 |
| 510k Number | K071281 |
| Device Name: | UNIRING - ANNULOPLASTY RING WITH SIZERS |
| Classification | Ring, Annuloplasty |
| Applicant | PETERS SURGICAL Z.I. LES VIGNES 42 RUE BENOIT FRACHON Bobigny, FR 93013 |
| Contact | Robert Renault |
| Correspondent | Robert Renault PETERS SURGICAL Z.I. LES VIGNES 42 RUE BENOIT FRACHON Bobigny, FR 93013 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-07 |
| Decision Date | 2007-08-03 |
| Summary: | summary |