The following data is part of a premarket notification filed by Teknimed Sa with the FDA for F20.
Device ID | K103433 |
510k Number | K103433 |
Device Name: | F20 |
Classification | Cement, Bone, Vertebroplasty |
Applicant | TEKNIMED SA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
Contact | J.d. Webb |
Correspondent | J.d. Webb TEKNIMED SA 1001 OAKWOOD BLVD Round Rock, TX 78681 |
Product Code | NDN |
CFR Regulation Number | 888.3027 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-11-24 |
Decision Date | 2011-01-03 |