The following data is part of a premarket notification filed by Patton, Boggs & Blow with the FDA for Manual Surgical Inst. And Acc. To Kls Mini Osteosynthesis System.
| Device ID | K943346 |
| 510k Number | K943346 |
| Device Name: | MANUAL SURGICAL INST. AND ACC. TO 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 |