The following data is part of a premarket notification filed by Cytori Therapeutics, Inc. with the FDA for Cytori Aft System.
Device ID | K072587 |
510k Number | K072587 |
Device Name: | CYTORI AFT SYSTEM |
Classification | System, Suction, Lipoplasty |
Applicant | CYTORI THERAPEUTICS, INC. 3020 CALLAN ROAD San Diego, CA 92121 -1109 |
Contact | Kenneth Kleinhenz |
Correspondent | Kenneth Kleinhenz CYTORI THERAPEUTICS, INC. 3020 CALLAN ROAD San Diego, CA 92121 -1109 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-09-14 |
Decision Date | 2007-12-10 |
Summary: | summary |