The following data is part of a premarket notification filed by Patton, Boggs & Blow with the FDA for Kls Mini Osteosynthesis System.
Device ID | K943347 |
510k Number | K943347 |
Device Name: | KLS MINI OSTEOSYNTHESIS SYSTEM |
Classification | Plate, Bone |
Applicant | PATTON, BOGGS & BLOW 2550 M ST. N.W. Washington, DC 20037 |
Contact | Mark A Heller |
Correspondent | Mark A Heller PATTON, BOGGS & BLOW 2550 M ST. N.W. Washington, DC 20037 |
Product Code | JEY |
CFR Regulation Number | 872.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-12 |
Decision Date | 1994-10-04 |