The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Kls-martin Mmf Screw.
Device ID | K980760 |
510k Number | K980760 |
Device Name: | KLS-MARTIN MMF SCREW |
Classification | Screw, Fixation, Intraosseous |
Applicant | KLS-MARTIN L.P. 3234 ELLA LN. New Port Richey, FL 34655 |
Contact | Patrick J Lamb |
Correspondent | Patrick J Lamb KLS-MARTIN L.P. 3234 ELLA LN. New Port Richey, FL 34655 |
Product Code | DZL |
CFR Regulation Number | 872.4880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-02-27 |
Decision Date | 1999-12-21 |
Summary: | summary |