The following data is part of a premarket notification filed by Kls Martin Lp with the FDA for Internal Distraction - Sterile.
| Device ID | K161470 |
| 510k Number | K161470 |
| Device Name: | Internal Distraction - Sterile |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | KLS MARTIN LP 11201 SAINT JOHNS INDUSTRIAL PKWY S Jacksonville, FL 32246 |
| Contact | Jennifer Damato |
| Correspondent | Gary Moore KLS MARTIN LP 11201 SAINT JOHNS INDUSTRIAL PKWY S Jacksonville, FL 32246 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-27 |
| Decision Date | 2016-12-01 |
| Summary: | summary |