The following data is part of a premarket notification filed by Genesee Biomedical, Inc. with the FDA for Ats Simulus Annuloplasty Band, Model 700fc.
Device ID | K052899 |
510k Number | K052899 |
Device Name: | ATS SIMULUS ANNULOPLASTY BAND, MODEL 700FC |
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 | 2005-10-14 |
Decision Date | 2005-11-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00643169301290 | K052899 | 000 |
00643169301153 | K052899 | 000 |
00643169301146 | K052899 | 000 |
00643169182493 | K052899 | 000 |
00643169182417 | K052899 | 000 |
00643169182400 | K052899 | 000 |
00643169182394 | K052899 | 000 |
00643169182387 | K052899 | 000 |
00643169182370 | K052899 | 000 |
00643169182363 | K052899 | 000 |
00643169182356 | K052899 | 000 |
00643169182349 | K052899 | 000 |
00643169301160 | K052899 | 000 |
00643169301177 | K052899 | 000 |
00643169301283 | K052899 | 000 |
00643169301276 | K052899 | 000 |
00643169301269 | K052899 | 000 |
00643169301252 | K052899 | 000 |
00643169301245 | K052899 | 000 |
00643169301238 | K052899 | 000 |
00643169301221 | K052899 | 000 |
00643169301214 | K052899 | 000 |
00643169301207 | K052899 | 000 |
00643169301191 | K052899 | 000 |
00643169301184 | K052899 | 000 |
00643169182332 | K052899 | 000 |