The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macropore Puricel Lipoplasty System.
Device ID | K042261 |
510k Number | K042261 |
Device Name: | MACROPORE PURICEL LIPOPLASTY SYSTEM |
Classification | System, Suction, Lipoplasty |
Applicant | MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
Contact | Kenneth K Kleinhenz |
Correspondent | Kenneth K Kleinhenz MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
Product Code | MUU |
CFR Regulation Number | 878.5040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-08-23 |
Decision Date | 2004-09-20 |
Summary: | summary |