The following data is part of a premarket notification filed by Genesee Biomedical, Inc. with the FDA for Ats Tri-ad Semi-flexible Tricuspid Anuuloplasty, Model 900sfc.
| Device ID | K093903 |
| 510k Number | K093903 |
| Device Name: | ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC |
| Classification | Ring, Annuloplasty |
| Applicant | Genesee BioMedical, Inc. 1308 SOUTH JASON ST. Denver, CO 80223 |
| Contact | John T.m. Wright |
| Correspondent | John T.m. Wright Genesee BioMedical, Inc. 1308 SOUTH JASON ST. Denver, CO 80223 |
| Product Code | KRH |
| CFR Regulation Number | 870.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-22 |
| Decision Date | 2010-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169301108 | K093903 | 000 |
| 00643169195356 | K093903 | 000 |
| 00643169195363 | K093903 | 000 |
| 00643169195370 | K093903 | 000 |
| 00643169195387 | K093903 | 000 |
| 00643169195394 | K093903 | 000 |
| 00643169301061 | K093903 | 000 |
| 00643169301078 | K093903 | 000 |
| 00643169301085 | K093903 | 000 |
| 00643169301092 | K093903 | 000 |
| 00643169195349 | K093903 | 000 |