The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Bnf.
Device ID | K021782 |
510k Number | K021782 |
Device Name: | BNF |
Classification | Nail, Fixation, Bone |
Applicant | AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE 12099 |
Contact | Dipl-ing Christian Abel |
Correspondent | Dipl-ing Christian Abel AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE 12099 |
Product Code | JDS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-05-30 |
Decision Date | 2002-08-26 |
Summary: | summary |