The following data is part of a premarket notification filed by Cytori Therapeutics, Inc. with the FDA for Puregraft 50 System.
Device ID | K132815 |
510k Number | K132815 |
Device Name: | PUREGRAFT 50 SYSTEM |
Classification | System, Suction, Lipoplasty |
Applicant | CYTORI THERAPEUTICS, INC. 3020 CALLAN ROAD San Diego, CA 92121 -1109 |
Contact | Kenneth K Kleinhenz |
Correspondent | Kenneth K 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 | 2013-09-09 |
Decision Date | 2014-01-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00863445000345 | K132815 | 000 |