The following data is part of a premarket notification filed by Teknimed Sa with the FDA for Cementek Lv.
Device ID | K042911 |
510k Number | K042911 |
Device Name: | CEMENTEK LV |
Classification | Filler, Bone Void, Calcium Compound |
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 | MQV |
CFR Regulation Number | 888.3045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-10-21 |
Decision Date | 2004-12-27 |
Summary: | summary |