The following data is part of a premarket notification filed by Memometal Technologies with the FDA for Memometal Memory Staples.
Device ID | K070031 |
510k Number | K070031 |
Device Name: | MEMOMETAL MEMORY STAPLES |
Classification | Staple, Fixation, Bone |
Applicant | MEMOMETAL TECHNOLOGIES RUE BLAISE PASCAL CAMPUS DE KER LANN Bruz, FR F35170 |
Contact | Gilles Audic |
Correspondent | Gilles Audic MEMOMETAL TECHNOLOGIES RUE BLAISE PASCAL CAMPUS DE KER LANN Bruz, FR F35170 |
Product Code | JDR |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-03 |
Decision Date | 2007-03-19 |
Summary: | summary |