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 |