The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Mod Line Of Molina Distractors, 51-600 Series.
Device ID | K994154 |
510k Number | K994154 |
Device Name: | MOD LINE OF MOLINA DISTRACTORS, 51-600 SERIES |
Classification | Plate, Bone |
Applicant | KLS-MARTIN L.P. 3234 ELLA LN. New Port Richey, FL 34655 |
Contact | Arthur Ward |
Correspondent | Arthur Ward KLS-MARTIN L.P. 3234 ELLA LN. New Port Richey, FL 34655 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-09 |
Decision Date | 2000-02-15 |
Summary: | summary |