The following data is part of a premarket notification filed by Kls-martin L.p. with the FDA for Kls-martin Rigid External Distraction Device.
| Device ID | K972047 |
| 510k Number | K972047 |
| Device Name: | KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | KLS-MARTIN L.P. 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| Contact | Ed Ransom |
| Correspondent | Ed Ransom KLS-MARTIN L.P. 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-02 |
| Decision Date | 1997-06-24 |