The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macropore Surgical Barrier Film.
Device ID | K023643 |
510k Number | K023643 |
Device Name: | MACROPORE SURGICAL BARRIER FILM |
Classification | Wrap, Implant, Orbital |
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 | MTZ |
CFR Regulation Number | 886.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-30 |
Decision Date | 2003-02-21 |
Summary: | summary |