The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macropore Fx, Ps, Ns, Lp.
Device ID | K012413 |
510k Number | K012413 |
Device Name: | MACROPORE FX, PS, NS, LP |
Classification | Plate, Bone |
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 | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-30 |
Decision Date | 2001-09-18 |
Summary: | summary |