The following data is part of a premarket notification filed by Genesee Biomedical, Inc. with the FDA for Ats Simulus Semi-rigid Mitral Annuloplasty Ring, Model 800sc.
Device ID | K083683 |
510k Number | K083683 |
Device Name: | ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC |
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 | 2008-12-12 |
Decision Date | 2009-02-25 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00643169300934 | K083683 | 000 |
00643169182134 | K083683 | 000 |
00643169182141 | K083683 | 000 |
00643169182158 | K083683 | 000 |
00643169182165 | K083683 | 000 |
00643169182172 | K083683 | 000 |
00643169182189 | K083683 | 000 |
00643169182196 | K083683 | 000 |
00643169182202 | K083683 | 000 |
00643169300880 | K083683 | 000 |
00643169300897 | K083683 | 000 |
00643169300903 | K083683 | 000 |
00643169300910 | K083683 | 000 |
00643169300927 | K083683 | 000 |
00643169182127 | K083683 | 000 |